DEPARTMENT OF HEALTH AND HUMAN SERVICE

Food and Drug AdmlnlslratlonNew Orleans DistrictImport Operallons959 Ridgeway Loop, Sulle 100Memphis, Tn. 38120

Telephone: (901) 333·3520FAX: (901)333-3579

Jauuary 7, 2011

UNITED PARCEL SERVICEDelivery Signature Requested

RE: Entry Number 112-9938358-2

This letter provides the status ofElltry Number 112-9938358-2, consisting ofl(b)f(~)lvialpackets, each vial containing 500 mg ofThiopental Sodium. FDA received documentationfor this shipment and verified it is destined fo1' a state correctional facility.

FDA releases this shipment, which is being imported by or on behalf of state correctionalauthorities. In keeping with established practice, FDA does not review or approve productsfor the purpose of lethal injection. FDA has not reviewed the products in this shipment todetermine their identity, safety, effectiveness, purity or any other characteristics.

Sincerely,

~~K.~~Patricia K. Schafei· J­Acting District DirectorNew Orleans District Office

FDA000029

Page 1 of1

alpenny, Susan M; Dixon, Ruth Pentry item # 112-99-38358-2

From: Boulmay, ChristopherSent; Tuesda November 3Q, 2010 4:00 PMTo:Ce:Sub.leet:~~iltr~~',;~;3'

- "", "... 'If-y·o~r~~~~. a~~i~~~~~~~~~:~70dn ~~e!~~~;8~ff~~~~~~~~j;~~n:'jDixon at 901-333-3522. I am not authorized to make an

admissibility decision on the entry.

Thank you,

~~Consumer Safety OfficerUS Food & Drug AdministrationNOL-DO: Memphis R.P.

Phone: (901) 333-3528Fax: (901)333-3577

Sent:

TO:.BO...•...•.u.• I.m~.~~f.hr. is..t.£.Ph~rCc: ~iliF{FI .~l~t:~\~fJ~~~ ,.···,,',~£l~

Subject: FDA entry item # 112-99-38358-2

Mr. Boulmay

I am inquirinbe sent toIX.message.

file:/IU:\SodiumThiopental\Emails\112-9938358-2Emails\RE FDA entry item # 112-99-38... 1/13/2011FDA000030

United States Food and Drug AdministrationNew Orleans District Office

Notice of FDA Action

Entry Number: 112-9938358-2 Notice Number: 2January 6, 2011

> <

November 24,2010November 19,2010

Port of Entry:Carrier:Date Received:Arrival Date:

Filer of Record:Consignee:

Memphis, TN

COMMERCIAL ENTRY CLOSED

Summary of Current Status of Individual Lines

.__.__ .._~i~_~._~~_~~~.'?.~ ~~?~~.~~..~~~.~~j.P..t~<?.~ _ _ _ _ _._ 9~.~.~~.i.~y. _. __.. __g!:J~r~~.~ ..~.t~.t~.~ .

* 001/001 688760418962 THIOPENTAL Released 01-06-2011

* = Status change since the previous notice. Read carefully the sections which follow for important informationregarding the~e lines.

@ = Consignee ID

This is the final notice concerning entry 112-9938358-2. Any status changes are reflected in the Line summary andline detail sections.

CORRESPONDENCE

.. ~i':l~J\~~t.~.~~ .. __ _..__ .._.. __ :~!~~.~~~.P~~~~p'~.i.?~_ .._.._..__ ..__ __._._ _ _ _ _ _ _.. __ _ __.._.001/001 688760418962 THIOPENTAL

Comments: FDA releases this shipment, which is being imported by or on beha'lf of state correctionalauthorities. In keeping with established practice, FDA does not review or approve products for thepurpose of lethal injection. FDA has not reviewed the products in t~is shipment to determine theiridentity, safety, effectiveness, purity or any other characteristics.

Randy N. Boling, Compliance Officer (Region/District) (901) 333-3537

U S F d d D A .. . (901) 333-3579 (FAX)• • 00 an rug dmlnlstratlon RANDY.BOLlNG@FDA.HHS.GOV

959 Ridgeway Loop Road, Suite 100Memphis, TN 38120-4042

FDA000031

Notice of FDA ActionEntry Number: 112-9938358-2

LINES RELEASED

Notice Number: 2Page: 2

...~!.~~.~~~!.~.l?~ ___ ~.~~~.~9.t.g~~~~!.I?t.i.~~ _.001/001 688760418962 THIOPENTAL

Randy N. Boling, Compliance Officer (Region/District) (901) 333-3537.• . (901) 333-3579 (FAX)

U.S. Food and Drug Administration RANDY.BOLlNG@FDA.HHS.GOV959 Ridgeway Loop Road, Suite 100Memphis, TN 38120-4042

These products are released. This notice does not constitute assurance that the product released complies with allprovisions of the Food, Drug, and Cosmetic Act, or other related Acts, and does not preclude action should theproduct later be found violative.

Notice Prepared For: The District Director, U.S. Food and Drug AdministrationNotice Prepared By: LPW

FDA000032

. TABS:

DEPARTMENT OF THE TREASURYUNITED STATES CUSTOMS SERVICE

Form ApJlf'MldOMS No. 1515-0069

ENTRY/IMMEDIATE DELIVERY ABI CERTIFIED

TEL:

AIR EXPRESS

1. ARRIVAL DATE

1119105. PORT

20955. SINGLE TRANS. BOND

4. ENTRY NUMBER

112-9938358-2

15. U.s. PORT OF UNLADING 17. MANIFEST NUMBER 18. Go. NUMBER 19. lOTAl VAWE

209520. DESCRIPTION OF MERCHANDISE

21. ITlBUAWB 22. mBUAWB NO.CODE

PHARMACEUTICALS NOT RESTRICTED25. COUNTRY 28. MANUFACTURER In.

OF ORIGIN

GBDREPHA176LONGBTOTAL02358560751688760418962

MH

'ZT. CERTIFICATION 28. CUSlOMS USE ONLY

I hBreby make application for entrynmmedlale delivery. I eertify thBtthe above D OTHER AGENCY ACTION REQUIRED, NAMELY:Information IB accurete, the bond Is sullielent, valid. and currant, and that allrequirements of 19 CFR Part 142 have been mst.

D CUSTOMS EXAMINATION REQUIRED.

:-=::-:=:=-=:=-=--!-::=7::=:::-:~=-=------1

-------------------------1 D ENTRY REJECTED, BECAUSE:

DELIVERYAUTHORIZED:

SIGNATURE

Customs Form 3461 (010189)

Papsrwork Reduction Act Notice: This information 18 needed to dstermlns the admissibility of imports Into the Unllsd Statae and 10 proVide the necessaryInformetlon for the examination of the cargo and to establish the liability for payment of dulleD Dnd taxeB. Your responDe Is neceBaery.

m~I11/24/10 12: 56: 42 ~

FDA000033

Dream Pharma Ltd.

Invoice DetailsNumber: 2727fNV

Tel:II(!2)J(lI)1f1

VAT no:Purchase Order:

Order Details

176 Horn Lane, Acton, Lond·on. W36PJTel: 020 8992 7000 Fax: 020 8992 7001E·Mall: info@dreampharma.com

Date: 19·11·2010

1.l(~)1raJ.jCurrency: USD - US DollarHeading: PHARMACEUTICALS NOT RESTRICTED

Name/Descri tionThiopental Injection. powder for reconstitution, thiopental sodium. 500·mg vial packs of 25's

Batch No: AW6022 EXP: 05/14

Statement Details

Discount (%):

Deli';'ery:~

Insurance:.

Shipping Details

Tariff:Declarations:We certify thallhis invoice is lrue and correct

Subtotal:""""'llL!!"""'=

VAT (World Zero):I(§Il~~

Previous Balance:.

Total: II1IDI<iJl USD • US Dollar

Pa menl Melhod: Pre a menl Thank You

Damage. shOrtage or leakage must be nollfied in writing 10 ourselves within 3 days. Non·Delivery within 14 days. GoodS remain Ihe property 0' DreamPharma Lid. Unlil fUll paymenl has been received. Subject 10 our standard conditiOns of sale. E&OE

Company Registration Number:lmIIDi VAT No. ~~~!:.!2~Director: M. Alavi

Page 1 of 1

FDA000034

lill1R}lr~"Manifest report

MPS shipment

pago·

FDA000035

FDA000036

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• NOTE-II. tOnln,,_ Dana Is on III... a DOIla no8\' IlhAI ;1I:campan~ 11111 crulnB" d0Clltl10nl

RETURN TO:.

AWBREF fl.:

I

12:DDpm

DEP1\R~MBN'l' OP THE TREMURYUNITED STATES CUSTOMS SERVICE

IMPORTER 10~ INPUT RECORD

Fill ZAQR 19

I ~~"-'010

6. Type••U.S. GDII~mmenl Olhl!l'

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.. CUSTOMSfORM.SI0Il(OIU'3)

FDA000037