Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – DRAFT FOOD FACILITY REGISTRATION FORM

USE BLUE OR BLACK INK ONLY

Date: (MM / DD / YYYY) (i) Section 1 – TYPE OF REGISTRATION (1) 1a. ð DOMESTIC REGISTRATION (1.1) ð FOREIGN REGISTRATION (1.2)

1b. ð INITIAL REGISTRATION (1.3) ð UPDATE REGISTRATION (1.4)

If update, provide the following Facility registration number: ________(1.4.1)________________PIN (1.4.2)_________________

Check all that apply and further identify changes in the applicable sections. (1.5)

ð United States Agent Change – Foreign Facility only (1.5.7)

ð Facility Address Change (see instructions) (1.5.1) ð Seasonal Facility Dates of Operation Change (1.5.8)

ð Facility Name Change (1.5.2) ð Type of Activity Change (1.5.9)

ð Preferred Mailing Address Change (1.5.3) ð Type of Storage Change (1.5.10)

ð Parent Company Change (1.5.4) ð Human Food Product Category Change (1.5.11)

ð Emergency contact Change (1.5.5) ð Animal Food Product Category Change (1.5.12)

ð Trade Name Change (1.5.6) ð Operator, or Agent in Charge Change. (1.5.13)

1c. ARE YOU THE OWNER OF A PREVIOUSLY REGISTERED FACILITY? YES ð NO ð If “yes” provide the following information, if known. (1.6)

Previous owner’s name: (1.6.1)

Previous owner’s number (1.6.2)

Section 2 – FACILITY NAME / ADDRESS INFORMATION (2)

FACILITY NAME: (2.1)

FACILITY STREET ADDRESS, Line 1

FACILITY STREET ADDRESS, Line 2

CITY: (2.3) STATE: (2.4)

ZIP CODE (POSTAL CODE): (2.5) PROVINCE / TERRITORY: (2.6)

COUNTRY: (2.7) PHONE NUMBER (Include Area/Country Code): (2.8)

FAX NUMBER (OPTIONAL; Include Area/Country Code): (2.9)

E-MAIL ADDRESS (OPTIONAL): (2.10)

FDA USE ONLY

(2.2)

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – FOOD FACILITY REGISTRATION FORM

Section 3 – PREFERRED MAILING ADDRESS INFORMATION complete this section only If different from Section 2, Facility Name / Address Information (OPTIONAL) (3) NAME: (3.1)

ADDRESS, Line 1

ADDRESS, Line 2

CITY: (3.3) STATE: (3.4)

ZIP CODE (POSTAL CODE): (3.5) PROVINCE / TERRITORY: (3.6)

COUNTRY: (3.7) PHONE NUMBER (Include Area/Country Code): (3.8)

FAX NUMBER (Include Area /Country Code): (3.9) E-MAIL ADDRESS: (3.10)

Section 4 – PARENT COMPANY NAME/ADDRESS INFORMATION (IF APPLICABLE AND IF DIFFERENT FROM, SECTIONS 2 AND 3). IF INFORMATION IS THE SAME AS ANOTHER SECTION, CHECK WHICH SECTION: SECTION 2 ð or SECTION 3 ð (4)

NAME OF PARENT COMPANY: (4.1)

STREET ADDRESS OF PARENT COMPANY, Line 1:

STREET ADDRESS OF PARENT COMPANY, Line 2:

CITY: (4.3) STATE: (4.4)

ZIP CODE (POSTAL CODE): (4.5) PROVINCE / TERRITORY: (4.6)

COUNTRY: (4.7) PHONE NUMBER (Include Area/Country Code): (4.8)

FAX NUMBER (Include Area/Country Code): (4.9) E-MAIL ADDRESS (OPTIONAL): (4.10)

Section 5 – FACILITY EMERGENCY CONTACT INFORMATION (5) (OPTIONAL FOR FOREIGN FACILITIES; FDA WILL USE YOUR U.S. AGENT AS YOUR EMERGENCY CONTACT UNLESS YOU CHOOSE TO DESIGNATE A DIFFERENT CONTACT HERE.)

INDIVIDUAL’S NAME (OPTIONAL): (5.1)

TITLE (OPTIONAL): (5.2) EMERGENCY CONTACT PHONE (Include Area/Country Code) (5.3)

E-MAIL ADDRESS (OPTIONAL): (5.4)

(3.2)

(4.2)

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – FOOD FACILITY REGISTRATION FORM

Section 6 – TRADE NAMES (IF THIS FACILITY USES TRADE NAMES OTHER THAN THAT LISTED IN SECTION 2 ABOVE, LIST THEM BELOW (E.G. “ALSO DOING BUSINESS AS,” “FACILITY ALSO KNOWN AS”): (6)

ALTERNATE TRADE NAME # 1: (6.1)

ALTERNATE TRADE NAME # 2: (6.2)

ALTERNATE TRADE NAME # 3: (6.3)

ALTERNATE TRADE NAME # 4: (6.4)

Section 7 – UNITED STATES AGENT (TO BE COMPLETED BY FACILITIES LOCATED OUTSIDE ANY STATE OR TERRITORY OF THE UNITED STATES, THE DISTRICT OF COLUMBIA, OR THE COMMONWEALTH OF PUERTO RICO.) (7)

NAME OF U.S. AGENT: (7.1)

TITLE (OPTIONAL): (7.2)

ADDRESS, Line 1:

ADDRESS, Line 2:

CITY: (7.4) STATE: (7.5) ZIP CODE: (7.6)

U.S. AGENT PHONE NUMBER (Include Area Code): (7.7)

EMERGENCY CONTACT PHONE NUMBER (Include Area Code): (7.8)

FAX NUMBER (OPTIONAL; Include Area Code) (7.9) E-MAIL ADDRESS (OPTIONAL): (7.10)

Section 8 - SEASONAL FACILITY DATES OF OPERATION (8) (GIVE THE APPROXIMATE DATES THAT YOUR FACILITY IS OPEN FOR BUSINESS, IF ITS OPERATIONS ARE ON A SEASONAL BASIS) (OPTIONAL)

DATES OF OPERATION: (8.1)

(7.3)

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – FOOD FACILITY REGISTRATION FORM

Section 9 – TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (9) (CHECK ALL TYPES OF OPERATIONS THAT ARE PERFORMED AT THIS FACILITY REGARDING THE MANUFACTURING/PROCESSING, PACKING OR HOLDING OF FOOD) (OPTIONAL)

q Warehouse / Holding Facility (e.g., storage facilities, including storage tanks, grain elevators) (9.1)

q Acidified/Low Acid Food Processor (9.2) q Labeler/Relabeler (9.3)

q Interstate Conveyance Caterer/Catering Point (9.4)

q Manufacturer/Processor (9.5)

q Molluscan Shellfish Establishment (9.6) q Repacker/Packer (9.7)

q Commisary (9.8) q Salvage Operator (Reconditioner) (9.9)

q Contract Sterilizer (9.10) q Animal food manufacturer / processor / holder (9.11)

Section 10 – TYPE OF STORAGE (FOR FACILITIES THAT ARE PRIMARILY HOLDERS) (OPTIONAL) (10)

q Ambient (neither frozen nor refrigerated) (10.1) Storage

q Refrigerated Storage (10.2) q Frozen Storage (10.3)

Section 11a – GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION (11) To be completed by all human food facilities Please see instructions for further examples. IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 37. Para acceder a los códigos de la FDA, utilizar la siguiente dirección de Internet: www.accessdata.fda.gov/scripts/ora/pcb/pcb.html Para acceder a los códigos del Registro Federal (FDA): www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1

ð 1. ALCOHOL BEVERAGES (11.1) [21CFR 170.3 (n) (2)] ð 2. BABY (INFANT AND JUNIOR) FOOD PRODUCTS (11.2) Including Infant Formula (Optional Selection) ð 3. BAKERY PRODUCTS, DOUGH MIXES, OR ICINGS (11.3) [21 CFR 170.3 (n) (1), (9)] ð 4. BEVERAGE BASES (11.4) [21 CFR 170.3 (n) (3), (16), (35)]

ð 5. CANDY WITHOUT CHOCOLATE, CANDY (11.5) SPECIALTIES & CHEWING GUM [21 CFR 170.3 (n) (6), (9), (25), (38)] ð 6. CEREAL PREPARATIONS, BREAKFAST FOODS, (11.6) QUICK COOKING/INSTANT CEREALS [21 CFR 170.3 (n) (4)] ð 7. CHEESE AND CHEESE PRODUCTS (11.7) [21CFR170.3 (N) (5)] ð 8. CHOCOLATE AND COCOA PRODUCTS (11.8) [21 CFR 170.3 (n) (3), (9), (38), (43)]

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – FOOD FACILITY REGISTRATION FORM

Section 11a – GENERAL PRODUCT CATEGORIES - FOOD FOR HUMAN CONSUMPTION To be completed by all human food facilities Please see instructions for further examples. IF NONE OF THE MANDATORY CATEGORIES BELOW APPLY, SELECT BOX 3 Para acceder a los códigos de la FDA, utilizar la siguiente dirección de Internet: www.accessdata.fda.gov/scripts/ora/pcb/pcb.html Para acceder a los códigos del Registro Federal (FDA): www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1

ð 9. COFEE AND TEA (11.9) [21 CFR 170.3 (n) (3), (7)]

ð 10. COLOR ADDITIVES FOR FOODS (11.10) [21 CFR 170.3 (o) (4)]

ð 11. DIETARY CONVENTIONAL FOODS OR MEAL (11.11) REPLACEMENTS (includes Medical Foods) [21 CFR 170.3 (n) (31)]

12. DIETARY SUPPLEMENTS (11.12)

ð Proteins, Amino Acids, Fats and Lipid Substances (11.12.1) [21 CFR 170.3 (o) (20)]

ð Vitamins and Minerals [21 CFR 170.3 (o) (20)] (11.12.2)

ð Animals By-Products and Extracts (Optional Selection) (11.12.3)

ð Herbals and Botanicals (Optional Selection) (11.12.4)

ð 13. DRESSINGS AND CONDIMENTS (11.13) [21 CFR 170.3 (n) (13), (15), (39), (40)]

ð 14. FISHERY/SEAFOOD PRODUCTS (11.14) [21 CFR 170.3 (n) (13), (15), (39), (40)

ð 15. FOOD ADDITIVES, GENERALLY RECOGNIZED AS SAFE (11.15) (GRAS) INGREDIENTS, OR OTHER INGREDIENTS USED FOR PROCESSING. [21 CFR 170.3 (n) (42); 21 CFR 170.3 (o) (1), (2), (3), (5), (6), (7), (8),(9), (10), (11), (12), (13), (14), (15), (16), (17), (18), (19), (22), (23), (24), (25), (26), (27), (28), (29), (30), (31), (32)

ð 16. FOOD SWEETENERS (NUTRITIVE) (11.16) [21 CFR 170.3 (n) (9), (41), 21 CFR 170.3 (o) (21)]

ð 17. FRUITS AND FRUIT PRODUCTS (11.17) [21 CFR 170.3 (n) (16), (27), (28), (35), (43)]

ð 18. GELATIN, RENNET, PUDDING MIXES, OR PIE FILLING (11.18) [21 CFR 170.3 (n) (22)]

ð 19. GELATIN, RENNET, PUDDING MIXES, OR PIE FILLING (11.19) [21 CFR 170.3 (n) (22)]

ð 20. IMITATION MILK PRODUCTS (11.20) [21 CFR 170.3 (n) (10)]

ð 21. MACARRONI OR NOODLE PRODUCTS (11.21) [21 CFR 170.3 (n) (23)]

ð 22. MEAT, MEAT PRODUCTS AND POULTRY (11.22) (FDA REGULATED) [21 CFR 170.3 (n) (17), (18), (29), (34), (39), (40)]

ð 23. MILK, BUTTER, OR DRIED MILK PRODUCTS (11.23) [21 CFR 170.3 (n) (12), (30), (31)]

ð 24. MULTIPLE FOOD DINNERS, GRAVIES, SAUCES AND (11.24) SPECIALTIES [21 CFR 170.3 (n) (11), (14), (17), (18), (23), (24), (29), (34), (40)]

ð 25 . NUT AND EDIBLE SEED PRODUCTS (11.25) [21 CFR 170.3 (n) (26), (32)]

ð 26. PREPARED SALAD PRODUCTS (11.26) [21 CFR 170.3 (n) (11), (14)]

ð 27. SHELL EGG AND EGG PODUCTS (11.27) [21 CFR 170.3 (n) (11), (14)]

ð 28. SNACK FOOD ITEMS (FLOUR, MEAL OR (11.28) VEGETABLE BASE) [21 CFR 170.3 (n) (37)]

ð 29. SPICES, FLAVORS, AND SALTS (11.29) [21 CFR 170.3 (n) (26)]

ð 30. SOUPS (11.30) [21 CFR 170.3 (n) (39), (40)]

ð 31. SOFT DRINKS AND WATERS (11.31) [21 CFR 170.3 (n) (3), (35)]

ð 32. VEGETABLES AND VEGETABLE PRODUCTS (11.32) [21 CFR 170.3 (n) (19), (36)]

ð 33. VEGETABLE OILS (INCLUDES OLIVE OIL) (11.33) [21 CFR 1703 (n) (12)]

ð 34. VEGETABLE PROTEIN PRODUCTS (SIMULATED (11.34) MEATS) [21 CFR 170.3 (n) (33)]

ð 35. WHOLE GRAINS, MILLER GRAIN PRODUCTS (11.35) (FLOURS), OR STARCH [21 CFR 170.3 (n) (1), (23)]

ð 36. MOST/ALL HUMAN FOOD PRODUCT CATEGORIES (11.36) (Optional Selection)

ð 37. NONE OF THE ABOVE MANDATORY CATEGORIES (11.37)

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – FOOD FACILITY REGISTRATION FORM

Section 11b – GENERAL PRODUCT CATEGORIES – FOOD FOR ANIMAL CONSUMPTION (12) (OPTIONAL)

ο 1. GRAIN PRODUCTS (E.G., BARLEY, GRAIN SORGHUMS, MAIZE, OAT RICE, RYE AND WHEAT) (12.1) ο 2. OILSEED PRODUCTS (E.G., COTTONSEED, SOYBEANS, OTHER OIL SEEDS) (12.2) ο 3. ALFALFA AND LESPEDEZA PRODUCTS (12.3) ο 4. AMINO ACIDS (12.4) ο 5. ANIMAL-DERIVED PRODUCTS (12.5) ο 6. BREWER PRODUCTS (12.6) ο 7. CHEMICAL PRESERVATIVES (12.7) ο 8. CITRUS PRODUCTS (12.8) ο 9. DISTILLERY PRODUCTS(12.9) ο 10. ENZYMES (12.10) ο 11. FATS AND OILS (12.11) ο 12. FERMENTATION PRODUCTS (12.12) ο 13. MARINE PRODUCTS (12.13)

ο 14. MILK PRODUCTS (12.14) ο 15 MINERALS (12.15) ο 16. MISCELLANEOUS AND SPECIAL PURPOSE (12.16) PRODUCTS ο 17. MOLASSES (12.17) ο 18. NON-PROTEIN NITROGEN PRODUCTS (12.18) ο 19. PEANUT PRODUCTS (12.19) ο 20. RECYCLED ANIMAL WASTE PRODUCTS (12.20) ο 21. SCREENINGS (12.21) ο 22. VITAMINS (12.22) ο 23. YEAST PRODUCTS (12.23) ο 24. MIXED FEED (POULTRY, LIVESTOCK, AND EQUINE) (12.24) ο 25. PET FOOD (12.25) ο 26. MOST/ALL ANIMAL FOOD PRODUCT CATEGORIES (12.26)

Section 12 – OWNER, OPERATOR, OR AGENT IN CHARGE INFORMATION (13)

NAME OF ENTITY OR INDIVIDUAL WHO IS THE OWNER, OPERATOR, OR AGENT IN CHARGE (13.1)

PROVIDE THE FOLLOWING INFORMATION, IF DIFFERENT FROM ALL OTHER SECTIONS ON THE FORM. IF INFORMATION IS

THE SAME AS ANOTHER SECTION OF THE FORM, CHECK WHICH SECTION: (13.2) SECTION 2 ð SECTION 3 ð SECTION 4 ð SECTION 5 ð STREET ADDRESS, Line 1:

STREET ADDRESS, Line 2:

CITY: (13.4) STATE: (13.5)

ZIP CODE (POSTAL CODE): (13.6) PROVINCE/TERRITORY: (13.7)

COUNTRY: (13.8) PHONE NUMBER (Include Area/CountryCode) (13.9)

FAX NUMBER (OPTIONAL; Include Area/Country E-MAIL ADDRESS (OPTIONAL): (13.11)

(13.3)

Code): (13.10)

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – FOOD FACILITY REGISTRATION FORM

Section 13 – CERTIFICATION STATEMENT (14) The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is the true and accurate and that he/she is authorized to submit this cancellation on the facility’s behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the cancellation. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or

fraudulent statement to the U.S. Government is subject to criminal penalties. (14.1) SIGNATURE OF SUBMITTER (14.2)

PRINT NAME OF THE SUBMITTER (14.3)

CHECK ONE BOX: ð A. OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM ES COMPLETED) (14.4)

ð B. INDIVIDUAL AUTHORIZED TO SUBMIT THE CANCELLATION (FILL IN BELOW) (14.5)

IF YOU CHECKED BOX B ABOVE, INDICATE WHO AUTHORIZED YOU TO SUBMIT THE CANCELLATION:

ð OWNER, OPERATOR, OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED) (14.6) ______________________________________________________________NAME OF INDIVIDUAL WHO AUTHORIZED

CANCELLATION ON BEHALF OF OWNER, OPERATOR , OR AGENT IN CHARGE (FILL IN BELOW) (14.7) ADDRESS INFORMATION FOR THE AUTHORIZING INDIVIDUAL: (14.8) AUTHORIZING INDIVIDUAL ADDRESS , Line 1:

AUTHORIZING INDIVIDUAL ADDRESS , Line 2:

CITY: (14.10) STATE: (14.11)

ZIP CODE (POSTAL CODE): (14.12) PROVINCE/TERRITORY: (14.13)

COUNTRY: (14.14) PHONE NUMBER (Include Area/Country Code): (14.15)

FAX NUMBER (OPCIONAL; Include Area / Country Code (14.16)

E-MAIL ADDRESS (OPCIONAL) (14.17):

MAIL COMPLETED FORM TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681, 5600

FISHERS LANE, ROCKVILLE, MD 20857, OR FAX IT TO (301) 210-0247.

FDA USE ONLY (15)

DATE CANCELLATION FORM RECEIVED (15.1)

DATE CONFIRMATION SENT TO FACILITY (15.2)

Public reporting burden for this collection of information is estimated to average between 1 al 12 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the date needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it

(14.9)

FSAN (HFS-024) 5100 Paint Branch Parkway College Park, MD 20740

displays a currently valid OMB control number.

Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

USE BLUE OR BLACK INK ONLY

DHHS/FDA – CANCELLATION OF FOOD FACILITY REGISTRATION FORM (16) FACILITY REGISTRATION NUMBER: (16.1) PIN: (16.2)

ð DOMESTIC REGISTRATION (16.3) ð FOREIGN REGISTRATION (16.4)

FACILITY NAME / ADDRESS INFORMATION (16.5) FACILITY NAME: (16.6) FACILITY STREET ADDRESS, Line 1: FACILITY STREET ADDRESS, Line 2: CITY: (16.8) STATE: (16.9) ZIP CODE (POSTAL CODE): (16.10) PROVINCE/TERRITORY: (16.11)

COUNTRY: (16.12) CERTIFICATION STATEMENT

The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is the true and accurate and that he/she is authorized to submit this cancellation on the facility’s behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the cancellation. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties. SIGNATURE OF SUBMITTER PRINT NAME OF THE SUBMITTER

CHECK ONE BOX: ð A. OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM ES COMPLETED) ð B. INDIVIDUAL AUTHORIZED TO SUBMIT THE CANCELLATION (FILL IN BELOW) IF YOU CHECKED BOX B ABOVE, INDICATE WHO AUTHORIZED YOU TO SUBMIT THE CANCELLATION:

ð OWNER, OPERATOR, OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED) ð ______________________________________________________________NAME OF INDIVIDUAL WHO AUTHORIZED

CANCELLATION ON BEHALF OF OWNER, OPERATOR , OR AGENT IN CHARGE (FILL IN BELOW) ADDRESS INFORMATION FOR THE AUTHORIZING INDIVIDUAL: AUTHORIZING INDIVIDUAL ADDRESS , Line 1: AUTHORIZING INDIVIDUAL ADDRESS , Line 2: CITY: STATE: ZIP CODE (POSTAL CODE): PROVINCE/TERRITORY: COUNTRY: PHONE NUMBER (Include Area/Country Code):

FDA USE ONLY DATE CANCELLATION FORM RECEIVED DATE CONFIRMATION SENT TO FACILITY

MAIL COMPLETED FORM TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681, 5600 FISHERS LANE, ROCKVILLE, MD 20857, OR FAX IT TO (301) 210-0247.

Public reporting burden for this collection of information is estimated to average between 1 al 12 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the date needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration FSAN (HFS-024)

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number.

FDA USE ONLY

(16.7)

(16.13)

5100 Paint Branch Parkway College Park, MD 20740

LLENADO DEL FORMATO DE REGISTRO DE INSTALACIONES

i.) FECHA la fecha se escribe mes / día / año. Usar solo tinta azul o negra. Ejemplo de llenado: Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

DHHS/FDA – DRAFT FOOD FACILITY REGISTRATION FORM

USE BLUE OR BLACK INK ONLY

Date 11/07/2003 (MM / DD / YYYY) (i)

FDA USE ONLY (USO EXCLUSIVO DEL FDA)

SECCIÓN 1 TIPO DE REGISTRO 1.) Indicar el tipo de registro que se está llenando; si se trata de “DOMESTIC”, se refiere a una instalación

dentro de E.U.A. o se trata de “FOREIGN” se refiere a una instalación extranjera, por ejemplo una instalación mexicana. 1.1. Registro de instalaciones dentro de E.U.A. 1.2. Registro de instalaciones fuera de E.U.A. 1.3. Registro inicial. Indicar si se trata de un registro inicial. 1.4. En caso de actualización, deberá escribir el número de registro que se le asigno en el registro inicial. 1.4.1. Si es actualización proveer el número de registro de la empresa. 1.4.2. Número de identificación personal. 1.5. Deberá marcar todas las opciones que apliquen en caso de ser una actualización, un cambio o una enmienda: 1.5.1. Cambio de Dirección (ver instrucciones) . 1.5.2. Cambio del Nombre de la Instalación.

1.5.3. Cambio del Domicilio para Recibir Correspondencia. 1.5.4. Cambio de Compañía Filial. 1.5.5. Cambio del Contacto para Emergencias. 1.5.6. Cambio del Nombre de la Marca. 1.5.7. Cambio del Agente en los Estados Unidos – Solo para países fuera de E.U.A 1.5.8. Cambio de Fechas Estacionales de Operación de la Instalación. 1.5.9.Cambio del Tipo de Actividad 1.5.10. Cambio del Tipo de Almacenamiento. 1.5.11. Cambio de Categoría de Producto para Consumo Humano. 1.5.12. Cambio de la Categoría de Alimento para Consumo Animal. 1.5.13. Cambio de Propietario, Operador, o Agente a Cargo.

1.6. ¿Es usted el nuevo dueño de una instalación registrada anteriormente? Nota. Si la respuesta es afirmativa y si conoce la información especifique: 1.6.1. Nombre del dueño anterior. 1.6.2. Número de registro del dueño anterior.

Ejemplo de llenado: Section 1 – TYPE OF REGISTRATION (1) 1a. ð DOMESTIC REGISTRATION (1.1)

FOREIGN REGISTRATION (1.2)

1b. INITIAL REGISTRATION (1.3) ð UPDATE REGISTRATION ( 1.4)

If update, provide the following Facility registration number: ________(1.4.1)___________________PIN___________(1.4.2)_______________________

Check all that apply and further identify (1.5) Changes in the applicable sections.

ð United States Agent Change – Foreign Facility only (1.5.7)

ð Facility Address Change (see instructions) ( 1.5.1) ð Seasonal Facility Dates of Operation Change ( 1.5.8)

ð Facility Name Change (1.5.2) ð Type of Activity Change (1.5.9)

ð Preferred Mailing Address Change (1.5.3) ð Type of Storage Change (1.5.10)

ð Parent Company Change (1.5.4) ð Human Food Product Category Change (1.5.11)

ð Emergency contact Change (1.5.5) ð Animal Food Product Category Change (1.5.12)

ð Trade Name Change (1.5.6) ð Operator, or Agent in Charge Change. (1.5.13)

1c. ARE YOU THE OWNER OF A PREVIOUSLY REGISTERED FACILITY? YES ð NO If “yes” provide the following information, if known. (1.6)

Previous owner’s name: (1.6.1)

Previous owner’s number: (1.6.2)

SECCIÓN 2. NOMBRE Y DIRECCIÓN DE LA INSTALACIÓN 2. Indicar los datos completos de la instalación.

2.1. Nombre. 2.2. Dirección. 2.3. Ciudad. 2.4. Estado. 2.5. Código postal. 2.6. Provincia o Territorio (para países con esa división política). 2.7. País. 2.8. Teléfono (incluyendo clave de país y ciudad). 2.9. FAX (incluyendo clave de país y ciudad). 2.10. Correo electrónico (opcional). Ejemplo de llenado:

Section 2 – FACILITY NAME / ADDRESS INFORMATION (2)

FACILITY NAME: Las Carretas S.A de C.V (2.1)

FACILITY STREET ADDRESS, Line 1 Miguel Hidalgo No. 5965

FACILITY STREET ADDRESS, Line 2

CITY: México (2.3) STATE: Distrito Federal (2.4)

ZIP CODE (POSTAL CODE): 04100 (2.5) PROVINCE / TERRITORY: (2.6)

COUNTRY México (2.7) PHONE NUMBER (Include Area/Country Code): (2.8) 52 (55) 55 54 03 41

FAX NUMBER (OPTIONAL; Include Area/Country Code): 52 (55) 55 54 03 16 (2.9)

E-MAIL ADDRESS (OPTIONAL): carretas@agrotec.com.mx (2.10)

( 2.2)

SECCIÓN 3. OPCIONAL: DIRECCIÓN DE PREFERENCIA PARA RECIBIR LA CORRESPONDENCIA 2.) OPCIONAL. Deberá llenarse la Sección 3, sólo en el caso de que el domicilio para recibir correspondencia sea diferente del domicilio de la instalación.

3.1. Nombre de la persona o instalación a la que será dirigida la correspondencia. 3.2. Dirección. 3.3. Ciudad. 3.4. Estado. 3.5. Código postal. 3.6. Provincia o Territorio (para países con esa división política). 3.7. País. 3.8. Teléfono (incluyendo clave de país y ciudad). 3.9. FAX (incluyendo clave de país y ciudad). 3.10. Correo electrónico. Ejemplo de llenado:

Section 3 - PREFERRED MAILING ADDRESS INFORMATION complete this section only if different from Section 2, Facility Name / Address Information (OPTIONAL) (3)

NAME: Fernando Gómez Gutiérrez (3.1)

ADDRESS, Line 1 Margaritas No. 265

ADDRESS, Line 2

CITY: México (3.3) STATE: Distrito Federal (3.4)

ZIP CODE (POSTAL CODE): 04300 (3.5) PROVINCE / TERRITORY: (3.6)

COUNTRY: México (3.7) PHONE NUMBER (Include Area/Country Code): 52 (55) 55 56 26 52 (3.8)

FAX NUMBER (Include Area /Country Code): (3.9) E-MAIL ADDRESS: fgomezg@prodigy.net.mx (3.10)

(3.2)

SECCIÓN 4. NOMBRE Y DIRECCIÓN DE LA COMPAÑÍA MATRIZ (EN CASO DE REQUERIRSE Y DE SER DIFERENTE DE LA SECCIÓN 2 Y SECCIÓN 3). SI LA INFORMACIÓN ES IGUAL AL DE ALGUNA DE LAS SECCIONES ANTERIORES MARCAR EN CUAL DE ELLAS. 4.) Datos generales de la Compañía. 4.1. Nombre de la compañía filial, subsidiaria o matriz. 4.2. Dirección. 4.3. Ciudad. 4.4. Estado. 4.5. Código postal. 4.6. Provincia o Territorio (para países con esa división política). 4.7. País. 4.8. Teléfono (incluyendo clave de país y ciudad). 4.9. FAX (incluyendo clave de país y ciudad). 4.10. Correo electrónico.

Ejemplo de llenado 1 (para el caso en que los datos anteriores sean de una compañía no filial o subsidiaria):

Section 4 – PARENT COMPANY NAME/ADDRESS INFORMATION (IF APPLICABLE AND IF DIFFERENT FROM, SECTIONS 2 AND 3). IF INFORMATION IS THE SAME AS ANOTHER SECTION, CHECK WHICH SECTION: SECTION 2 ð or SECTION 3 ð (4)

NAME OF PARENT COMPANY: (4.1)

STREET ADDRESS OF PARENT COMPANY, Line 1:

STREET ADDRESS OF PARENT COMPANY, Line 2:

CITY: (4.3) STATE: (4.4)

ZIP CODE (POSTAL CODE): (4.5) PROVINCE / TERRITORY: (4.6)

COUNTRY: (4.7) PHONE NUMBER (Include Area/Country Code): (4.8)

FAX NUMBER (Include Area/Country Code): (4.9) E-MAIL ADDRESS (OPTIONAL): (4.10)

Ejemplo de llenado 2 (para el caso en que los datos anteriores sean de una compañía filial o subsidiaria):

Section 4 – PARENT COMPANY NAME/ADDRESS INFORMATION (IF APPLICABLE AND IF DIFFERENT FROM, SECTIONS 2 AND 3). IF INFORMATION IS THE SAME AS ANOTHER SECTION, CHECK WHICH SECTION: SECTION 2 ð or SECTION 3 ð (4) NAME OF PARENT COMPANY: Campo Azul S.A. de R.L. (4.1)

STREET ADDRESS OF PARENT COMPANY, Line 1: Revolución No. 5622

STREET ADDRESS OF PARENT COMPANY, Line 2:

CITY: México (4.3) STATE: Distrito Federal (4.4)

ZIP CODE (POSTAL CODE):04800 (4.5) PROVINCE / TERRITORY: (4.6)

COUNTRY: México (4.7) PHONE NUMBER (Include Area/Country Code): 52 (55) 58 59 45 52 (4.8)

(4.2)

(4.2)

FAX NUMBER (Include Area/Country Code): 52 (55) 58 59 45 16 (4.9)

E-MAIL ADDRESS (OPTIONAL): campoazul@agro.com.mx (4.10)

SECCIÓN 5. CONTACTO DE EMERGENCIA DE LA INSTALACIÓN La FDA tomará a su agente en los Estados Unidos como su contacto de emergencia, al menos que usted escoja uno diferente, si es así, entonces llenar la sección 5. 5.) Datos generales de la persona que se encuentre en la instalación para casos de emergencia.

5.1. Nombre. 5.2. Cargo en la instalación (opcional). 5.3 Teléfono para casos de emergencia (incluyendo clave de país y ciudad). 5.4. Correo electrónico. Ejemplo de llenado 1 (para el caso en que se decida no tener otro contacto):

Section 5 – FACILITY EMERGENCY CONTACT INFORMATION (OPTIONAL FOR FOREIGN FACILITIES; FDA WILL USE YOUR U.S. AGENT AS YOUR EMERGENCY CONTACT UNLESS YOU CHOOSE TO DESIGNATE A DIFFERENT CONTACT HERE.) (5) INDIVIDUAL’S NAME (OPTIONAL): (5.1)

TITLE (OPTIONAL): (5.2) EMERGENCY CONTACT PHONE (Include Area/Country Code) (5.3)

E-MAIL ADDRESS (OPTIONAL): (5.4)

Ejemplo de llenado 2 (para el caso en que se decida tener otro contacto):

Section 5 – FACILITY EMERGENCY CONTACT INFORMATION (OPTIONAL FOR FOREIGN FACILITIES; FDA WILL USE YOUR U.S. AGENT AS YOUR EMERGENCY CONTACT UNLESS YOU CHOOSE TO DESIGNATE A DIFFERENT CONTACT HERE.) (5)

INDIVIDUAL’S NAME (OPTIONAL): José Juan Ramírez Sánchez (5.1)

TITLE (OPTIONAL): Asistente Técnico (5.2) EMERGENCY CONTACT PHONE (Include Area/Country Code) (714) 722 93 56 (5.3)

E-MAIL ADDRESS (OPTIONAL): josejuan@correoweb.com (5.4)

SECCIÓN 6. MARCAS COMERCIALES 6.) Marcas comerciales de los productos.- Llenar sólo en caso de que los marcas comerciales difieran del nombre de la instalación especificado en la Sección 2.

6.1. Nombre comercial alternativo No. 1 6.2. Nombre comercial alternativo No. 2 6.3. Nombre comercial alternativo No. 3 6.4. Nombre comercial alternativo No. 4 Ejemplo de llenado:

Section 6 – TRADE NAMES (IF THIS FACILITY USES TRADE NAMES OTHER THAN THAT LISTED IN SECTION 2 ABOVE, LIST THEM BELOW (E.G. “ALSO DOING BUSINESS AS,” “FACILITY ALSO KNOWN AS”): (6)

ALTERNATE TRADE NAME # 1: Enchilositos (6.1)

ALTERNATE TRADE NAME # 2: Frutilocos (6.2)

ALTERNATE TRADE NAME # 3: (6.3)

ALTERNATE TRADE NAME # 4: (6.4)

SECCIÓN 7. AGENTE EN LOS ESTADOS UNIDOS DE AMÉRICA Completarse por las instalaciones foráneas (México).

7.) Agente en los Estados Unidos de América.

7.1. Nombre del Agente. 7.2. Cargo en la instalación (opcional). 7.3. Dirección. 7.4. Ciudad. 7.5. Estado. 7.6. Código Postal. 7.7. Teléfono del agente en los E.U.A. 7.8. Teléfono para contactos en caso de emergencia (incluyendo clave de país y ciudad). 7.9. Fax (incluyendo clave de país y ciudad). 7.10. Correo electrónico. Ejemplo de llenado:

Section 7 – UNITED STATES AGENT (TO BE COMPLETED BY FACILITIES LOCATED OUTSIDE ANY STATE OR TERRITORY OF THE UNITED STATES, THE DISTRICT OF COLUMBIA, OR THE COMMONWEALTH OF PUERTO RICO.) (7)

NAME OF U.S. AGENT: John Smith (7.1)

TITLE (OPTIONAL): General Manager (7.2)

ADDRESS, Line 1: Hillview Avenue No. 234

ADDRESS, Line 2:

CITY: Los Angeles (7.4) STATE: California (7.5) ZIP CODE: 90210 (7.6)

U.S. AGENT PHONE NUMBER (Include Area Code): (714) 721 33 94 (7.7)

EMERGENCY CONTACT PHONE NUMBER (Include Area Code): (714) 721 45 34 (7.8)

FAX NUMBER (OPTIONAL; Include Area Code) (714) 721 33 56 (7.9)

E-MAIL ADDRESS (OPTIONAL): jsmith@aol.com (7.10)

(7.3)

SECCIÓN 8. OPCIONAL: FECHAS DE OPERACIÓN DE LA INSTALACIÓN DURANTE LA TEMPORADA 8.) OPCIONAL. Fechas en las que opera la instalación dentro de la temporada (dar fechas aproximadas en las que se encuentre la instalación lista para realizar cualquier negocio concerniente a la temporada de exportación del producto).

8.1. Fechas en las que se opera. Ejemplo de llenado:

Section 8 - SEASONAL FACILITY DATES OF OPERATION (GIVE THE APPROXIMATE DATES THAT YOUR FACILITY IS OPEN FOR BUSINESS, IF ITS OPERATIONS ARE ON A SEASONAL BASIS) (OPTIONAL) (8)

DATES OF OPERATION: 1ro de Junio al 30 de noviembre (8.1)

SECCIÓN 9. OPCIONAL: TIPO DE OPERACIONES QUE REALIZA LA INSTALACIÓN. 9.) OPCIONAL. Tipo de operaciones que se realizan en la instalación.

9.1. Bodega o instalación de almacenaje; ejemplo: instalaciones para almacenamiento, tanques de almacenamiento, elevadores para granos, etc.

9.2. Proceso de alimentos acidificados o de baja acidez. 9.3. Etiquetadora o reetiquetadora. 9.4. Centro de acopio interestatal o central de abastos. 9.5. Manufacturera o procesadora. 9.6. Establecimiento de mariscos y moluscos. 9.7. Empaquetadora o reempaquetadora. 9.8. Comisariato. 9.9. Procesadora de residuos (Reacondicionadora). 9.10. Esterilizadora de contrato. 9.11. Manufacturera, procesadora o retenedora de comida para animales. Ejemplo de llenado

Section 9 – TYPE OF ACTIVITY CONDUCTED AT THE FACILITY (9) (CHECK ALL TYPES OF OPERATIONS THAT ARE PERFORMED AT THIS FACILITY REGARDING THE MANUFACTURING/PROCESSING, PACKING OR HOLDING OF FOOD) (OPTIONAL)

q Warehouse / Holding Facility (e.g., storage facilities, including storage tanks, grain elevators) (9.1)

q Acidified/Low Acid Food Processor (9.2) q Labeler/Relabeler (9.3)

q Interstate Conveyance Caterer/Catering Point (9.4)

Manufacturer/Processor (9.5)

q Molluscan Shellfish Establishment (9.6) q Repacker/Packer (9.7)

q Commisary (9.8) q Salvage Operator (Reconditioner) (9.9)

q Contract Sterilizer (9.10) q Animal food manufacturer / processor / holder (9.11)

SECCIÓN 10. OPCIONAL: SI TU INSTALACIÓN ES: UN ALMACÉN O UNA BODEGA COMPLETA ESTA SECCIÓN 10.) Este punto es opcional y únicamente deberás llenarlo si tu instalación es un almacén o una bodega.

10.1. Almacenamiento a temperatura ambiente. 10.2. Almacenamiento refrigerado. 10.3. Almacenamiento congelado. Ejemplo de llenado:

Section 10 – TYPE OF STORAGE (FOR FACILITIES THAT ARE PRIMARILY HOLDERS) (OPTIONAL) (10)

q Ambient (neither frozen nor refrigerated) (10.1) Storage

Refrigerated Storage (10.2) q Frozen Storage (10.3)

SECCIÓN 11a. CATEGORIAS GENERALES DE LOS PRODUCTOS – COMIDA PARA CONSUMO HUMANO 11.) Deberá ser llenada sólo sí cuentas con instalaciones que procesan alimentos de consumo humano y deberás señalar el tipo de alimentos que procesas, si no encuentras la categoría a la que correspondes marca la opción 37.

11.1. Bebidas alcohólicas. 11.2. Comida para bebé (infantes y niños), incluyendo fórmula para bebés (Selección opcional). 11.3. Pastelería, mezclas de pastas o betún. 11.4. Bases para bebidas. 11.5. Dulces sin chocolate, especialidades de dulces y gomas de mascar. 11.6. Preparaciones a base de cereales, desayunos, comida rápida y cereales instantáneos. 11.7. Quesos o productos de quesos. 11.8. Chocolates y productos de cacao. 11.9. Café y té. 11.10. Colorantes para alimentos. 11.11. Comidas de dietas convencionales ó reemplazos de comidas.(incluye comidas medicinales). 11.12. Suplementos de dietas.

11.12.1. Proteínas, aminoácidos, substancias de grasa y lípidos. 11.12.2. Vitaminas y minerales. 11.12.3. Productos de origen animal y extractos (selección opcional). 11.12.4. Herbolaria y Botánica (selección opcional).

11.13. Condimentos y aderezos. 11.14. Pescados y Mariscos. 11.15. Aditivos alimenticios, generalmente reconocidos como ingredientes seguros “gras”, u otros ingredientes usados para procesar. 11.16. Endulcorantes nutritivos. 11.17. Frutas o productos a base de frutas. 11.18. Gelatinas, cuajos, mezclas para pudines y rellenos para pays. 11.19. Helados y productos relacionados. 11.20. Productos imitación de leche. 11.21. Macarrones y pastas. 11.22. Carnes, productos cárnicos y productos avícolas. 11.23. Leche, mantequilla o productos lácteos deshidratados. 11.24. Diferentes comidas para cena, salsas, y especialidades. 11.25. Nuez y semillas comestibles. 11.26. Ensaladas preparadas. 11.27. Huevo en cascarón y productos a base de huevo. 11.28. Botanas (a base de harinas y granos molidos). 11.29. Especies, saborizantes y sales. 11.30. Sopas. 11.31. Bebidas refrescantes y agua. 11.32. Vegetales y productos a base de vegetales. 11.33. Aceites vegetales (incluye el aceite de olivo). 11.34. Productos a base de proteínas vegetales (imitación de carnes). 11.35. Granos enteros, productos a base de granos molidos (harinas) ó almidón. 11.36. La mayoría o todas las categorías de productos para consumo humano. (selección opcional). 11.37. Ninguna de las categorías anteriores. Ejemplo de llenado:

17. FRUITS AND FRUIT PRODUCTS (11.17) [21 CFR 170.3 (n) (16), (27), (28), (35), (43)]

ð 34. VEGETABLE PROTEIN PRODUCTS (SIMULATED MEATS) [21 CFR 170.3 (n) (33)] (11.34)

SECCIÓN 11b. CATEGORIAS GENERALES OPCIONALES PARA LOS PRODUCTOS DE CONSUMO ANIMAL

12.) Deberá ser llenada si cuentas con instalaciones que procesen alimentos para consumo animal. 12.1. Productos de granos (cebada, maíz, arroz, sorgo, centeno y trigo, etc). 12.2. Productos de semillas oleaginosa (semilla de soya, semilla de algodón, etc). 12.3. Productos de alfalfa y lespedeza. 12.4. Aminoácidos. 12.5. Productos de origen animal . 12.6. Productos para cerveza. 12.7. Conservadores químicos. 12.8. Productos a base de cítricos. 12.9. Productos derivados de destilación. 12.10. Enzimas. 12.11. Grasas y aceites. 12.12. Productos derivados de fermentaciones. 12.13. Productos de origen marino. 12.14. Productos a base de leche. 12.15. Minerales. 12.16. Misceláneos y productos para propósitos especiales. 12.17. Melazas . 12.18. Productos a base de nitrógeno no proteico. 12.19. Productos a base de cacahuates. 12.20. Productos derivados de reciclaje de productos animales. 12.21. Desperdicios de cribado. 12.22. Vitaminas. 12.23. Productos a base de levaduras. 12.24. Mezclas de alimentos (avícolas, ganadería y equinos). 12.25. Comida para mascotas. 12.26. La mayoría o todas las categorías de productos para consumo animal (selección opcional).

Ejemplo de llenado:

Section 11b – GENERAL PRODUCT CATEGORIES – FOOD FOR ANIMAL CONSUMPTION (OPTIONAL) (12)

ο 1. GRAIN PRODUCTS (E.G., BARLEY, GRAIN SORGHUMS, MAIZE, OAT RICE, RYE AND WHEAT) (12.1) ο 2. OILSEED PRODUCTS (E.G., COTTONSEED, SOYBEANS,

OTHER OIL SEEDS) (12.2) ο 3. ALFALFA AND LESPEDEZA PRODUCTS (12.3) ο 4. AMINO ACIDS (12.4) ο 5. ANIMAL-DERIVED PRODUCTS (12.5) ο 6. BREWER PRODUCTS (12.6) ο 7. CHEMICAL PRESERVATIVES (12.7) ο 8. CITRUS PRODUCTS (12.8) ο 9. DISTILLERY PRODUCTS (12.9) ο 10. ENZYMES (12.10) ο 11. FATS AND OILS (12.11) ο 12. FERMENTATION PRODUCTS (12.12) ο 13. MARINE PRODUCTS (12.13)

ο 14. MILK PRODUCTS (12.14) ο 15 MINERALS (12.15) ο 16. MISCELLANEOUS AND SPECIAL PURPOSE PRODUCTS (12.16) ο 17. MOLASSES (12.17) ο 18. NON-PROTEIN NITROGEN PRODUCTS (12.18) ο 19. PEANUT PRODUCTS (12.19) ο 20. RECYCLED ANIMAL WASTE PRODUCTS (12.20) ο 21. SCREENINGS (12.21) ο 22. VITAMINS (12.22) ο 23. YEAST PRODUCTS (12.23) ο 24. MIXED FEED (POULTRY, LIVESTOCK, AND EQUINE) (12.24) ο 25. PET FOOD (12.25) ο 26. MOST/ALL ANIMAL FOOD PRODUCT CATEGORIES (12.26)

SECCIÓN 12.- INFORMACIÓN DEL DUEÑO, OPERADOR O AGENTE A CARGO DE LA INSTALACIÓN. 13) Información del dueño, operador, o agente a cargo de la instalación. 13.1. Nombre la entidad o individuo quién es el dueño, operador o agente a cargo de la instalación. 13.2. Proveer la siguiente información, si difiere de alguna de la secciones anteriores. Si la información es la misma que existe en alguna otra sección, marcar en cual de ellas. 13.3. Dirección. 13.4. Ciudad. 13.5. Estado. 13.6. Código postal. 13.7. Provincia o Territorio. 13.8. País. 13.9. Teléfono (incluyendo clave de país y ciudad). 13.10. FAX (incluyendo clave de país y ciudad). 13.11. Correo electrónico (opcional).

Ejemplo de llenado:

Section 12 – OWNER, OPERATOR, OR AGENT IN CHARGE INFORMATION (13)

NAME OF ENTITY OR INDIVIDUAL WHO IS THE OWNER, OPERATOR, OR AGENT IN CHARGE (13.1) Fernando Gómez Gutiérrez

PROVIDE THE FOLLOWING INFORMATION, IF DIFFERENT FROM ALL OTHER SECTIONS ON THE FORM. IF INFORMATION IS THE SAME AS ANOTHER SECTION OF THE FORM, CHECK WHICH SECTION: (13.2) SECTION 2 ð SECTION 3 ð SECTION 4 ð SECTION 5 ð STREET ADDRESS, Line 1:

(13.3)

STREET ADDRESS, Line 2:

CITY: (13.4) STATE: (13.5)

ZIP CODE (POSTAL CODE): (13.6) PROVINCE/TERRITORY: (13.7)

COUNTRY: (13.8) PHONE NUMBER (Include Area/CountryCode) (13.9)

FAX NUMBER (OPTIONAL; Include Area/Country Code): (13.10)

E-MAIL ADDRESS (OPTIONAL): (13.11)

SECCIÓN 13.- CERTIFICACIÓN DE AUTENTICIDAD.

14.) Certificación de autenticidad.- El dueño, operador de la instalación o el individuo autorizado por el dueño, operador o agente a cargo de la instalación debe entregar esta forma.

14.1. Declaratoria de autenticidad En esta sección tu declaras que la información que has proporcionado es verídica y que te serás acreedor a un sanción en caso de haber mentido, de acuerdo a lo previsto en la ley.

14.2. Firma del responsable que entrega la forma. 14.3. Nombre escrito a mano del responsable que entrega la forma. 14.4. Si eres el dueño, operador o agente a cargo de la instalación, aquí terminaste, se ha completado el llenado. 14.5 Si eres una persona autorizada para la cancelación del formato, llenar la parte de abajo. 14.6 Solo se llenara si aplicas para 14.5. Indica quién te autorizo para cancelar el formato; Si fue el dueño, el operador o el agente a cargo, has terminado el llenado. 14.7. Nombre de la persona que te autorizo para la cancelación del formato, si aplica esta opción llenar la parte de abajo. 14.8 Dirección de la persona que autorizo la cancelación del registro. 14.9 Dirección de la persona que cancela el registro. 14.10 Ciudad. 14.11 Estado. 14.12 Código postal. 14.13 Provincia o Territorio. 14.14 País. 14.15 Teléfono (con códigos de país y ciudad). 14.16 FAX (opcional). 14.17 Correo electrónico (opcional).

Ejemplo de llenado:

Section 13 – CERTIFICATION STATEMENT (14) The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is the true and accurate and that he/she is authorized to submit this cancellation on the facility’s behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the cancellation. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties. (14.1) SIGNATURE OF SUBMITTER Rodrigo (14.2)

PRINT NAME OF THE SUBMITTER Rodrigo Ramírez Pérez (14.3)

CHECK ONE BOX: ð A. OWNER, OPERATOR OR AGENT IN CHARGE (STOP HERE, FORM ES COMPLETED) (14.4)

ð B. INDIVIDUAL AUTHORIZED TO SUBMIT THE CANCELLATION (FILL IN BELOW) (14.5)

IF YOU CHECKED BOX B ABOVE, INDICATE WHO AUTHORIZED YOU TO SUBMIT THE CANCELLATION:

ð OWNER, OPERATOR, OR AGENT IN CHARGE (STOP HERE, FORM IS COMPLETED) (14.6) ______________________________________________________________NAME OF INDIVIDUAL WHO AUTHORIZED

CANCELLATION ON BEHALF OF OWNER, OPERATOR , OR AGENT IN CHARGE (FILL IN BELOW) (14.7) ADDRESS INFORMATION FOR THE AUTHORIZING INDIVIDUAL: (14.8) AUTHORIZING INDIVIDUAL ADDRESS , Line 1: AUTHORIZING INDIVIDUAL ADDRESS , Line 2:

CITY: (14.10) STATE: (14.11)

ZIP CODE (POSTAL CODE): (14.12) PROVINCE/TERRITORY: (14.13) COUNTRY: (14.14) PHONE NUMBER (Include Area/Country Code): (14.15) FAX NUMBER (OPCIONAL; Include Area / Country Code (14.16)

E-MAIL ADDRESS (OPCIONAL) (14.17):

USO EXCLUSIVO DEL FDA, NO LLENAR

MAIL COMPLETED FORM TO U.S. FOOD AND DRUG ADMINISTRATION, HFS-681, 5600 FISHERS LANE, ROCKVILLE, MD 20857, OR FAX IT TO (301) 210-0247.

FDA USE ONLY (15)

DATE CANCELLATION FORM RECEIVED (15.1)

DATE CONFIRMATION SENT TO FACILITY (15.2)

Public reporting burden for this collection of information is estimated to average between 1 al 12 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the date needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration FSAN (HFS-024) 5100 Paint Branch Parkway College Park, MD 20740

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number.

(14.9)

SECCIÓN 16.- FORMATO DE CANCELACIÓN PARA EL REGISTRO DE INSTALACIONES DE ALIMENTOS DHHS/FDA (USAR TINTA NEGRA SOLAMENTE). 16) Formato de cancelación para el registro de instalaciones de alimentos DHHS/FDA

16.1. Número de registro de la instalación. 16.2. Número de identificación personal. 16.3. Registro para instalaciones en los E.U.A. 16.4. Registro para instalaciones fuera de los E.U.A. (Foráneas). 16.5. Nombre y dirección de la instalación. 16.6. Nombre de la instalación. 16.7. Dirección de la instalación. 16.8. Ciudad. 16.9. Estado. 16.10. Código postal. 16.11. Provincia o Territorio. 16.12. País. 16.13. REMITIRSE A LA SECCIÓN 13 Ejemplo de llenado: Form Approval: OMB No. 0910-xxxx Expiration Date: See OMB Statement at end of form

USE BLUE OR BLACK INK ONLY

DHHS/FDA – CANCELLATION OF FOOD FACILITY REGISTRATION FORM (16) FACILITY REGISTRATION NUMBER: 2568(16.1) PIN:42725 (16.2)

FDA USE ONLY (USO EXCLUSIVO DEL FDA)

ð DOMESTIC REGISTRATION (16.3) ð FOREIGN REGISTRATION (16.4)

FACILITY NAME / ADDRESS INFORMATION (16.5) FACILITY NAME: Las Carretas S.A de C.V (16.6) FACILITY STREET ADDRESS, Line 1: Miguel Hidalgo No. 5965 FACILITY STREET ADDRESS, Line 2: CITY: México (16.8) STATE: Distrito Federal (16.9) ZIP CODE (POSTAL CODE): 04100 (16.10) PROVINCE/TERRITORY: (16.11)

COUNTRY: México (16.12) CERTIFICATION STATEMENT (16.13)

The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. An individual (other than the owner, operator, or agent in charge of the facility) who submits the form to the FDA also certifies that the above information submitted is the true and accurate and that he/she is authorized to submit this cancellation on the facility’s behalf. An individual authorized by the owner, operator, or agent in charge must below identify by name the individual who authorized submission of the cancellation. Under 18 U.S.C. 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.

(16.7)