FDA Approach to Auditing

8/3/2019 FDA Approach to Auditing

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25 Sept. 2003 Frankfurt, Germany 1

U.S. FDA Approach to

Auditing Including QSIT

Christine Nelson

Center for Devices & Radiological Health

Food & Drug Administration


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FDA-Speak Terms

Inspection = Audit

I

nvestigator = Auditor


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Why does FDA inspect device

manufacturers?To evaluate compliance with the

following FDA device regulations:

Quality SystemsMedical Device Reporting

Medical Device Tracking

Reports of Corrections andRemovals

Registration and Listing


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Who conducts inspections for FDA?

1. FDA investigators in 20 FDA District

Offices around the U.S.

2. FDA-trained Auditors from ConformityAssessment Bodies in the European

Union (EU)

3. In the future, FDA-trained auditors fromindependent third parties accredited by

FDA


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How does FDA decide who to

inspect?Registration database identifies who

manufactures devices for distribution in

the U.S. Listing database identifies what devices

they distribute

FDA prioritizes inspections by risk andgives higher risk devices/situations ahigher priority


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What is high priority for inspection?

Device manufacturers that:

Make class III devices

Make implantable devices and life

supporting and life sustaining devices

Recently introduced a new device to the

market

Have had significant violations in the

past


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Does FDA notify the manufacturer

of an upcoming inspection?FDA calls domestic manufacturers about

5 days before the inspection

FDA contacts foreign manufacturers 2 - 3

months in advance to schedule inspection

Manufacturer is requested to send QualitySystem Manual or equivalent for pre-

inspection review


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What happens when the FDA

investigator arrives at the site?The FDA investigator will:

Ask to see the top management

Present credentials (identifies person

as an FDA investigator)

Issue notice of inspection explainingFDAs legal authority to inspect (only

in the U.S.)


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What happens during the

inspection? Investigator may tour the facility to get

an idea of layout, workflow, and areas

that may need closer inspection

This helps the investigator

decide how to organizethe inspection


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What happens next?

The investigator will:

Ask about size and structure of

company, who is in charge, whatproducts are manufactured there

Review registration and listing

Evaluate compliance with FDAregulations using the Quality SystemInspection Technique (QSIT)


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What is QSIT?

GGUIDEUIDETOTO IINSPECTIONSNSPECTIONSOFOF

QQUALITYUALITY SSYSTEMSYSTEMS

F O O D A N D D R U G

A D M I N I S T R A T I O N

August 1999August 1999

www.fda.gov/ora/in

spect_ref/igs/qsit/q

sitguide.htm


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What is QSIT?

Identifies 4 major subsystems to

evaluate and states the purpose and

importance of each subsystem

Provides flowcharts and inspectional

objectives to cover during inspection

Offers adviceProvides tables for statistical sampling

of records for review


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What are the four main subsystems?

DesignControls

MaterialControls Records,

Documents, &

Change Controls

Equipment &Facility Controls

Production &Process Controls

Corrective &

Preventive

Actions

Management


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What does FDA look for in the

Management Subsystem?Quality Policy established?

Management representative

appointed?

Management reviews conducted?


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Management Subsystem?Quality audit procedures

established and quality audits

conducted?

Quality plan established?

Quality system proceduresestablished?


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Design Control Subsystem?Design procedures and plan established?

Design inputs or requirements for device

identified?

Design outputs or specifications for

device identified?

Design verification conducted?

Design validation conducted?


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Design Control Subsystem?Software validation completed?

Risk analysis carried out?

Design reviews conducted?

Design transfer to manufacturingcompleted successfully?


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What does FDA look for in the Corrective

and Preventive Action Subsystem?

CAPA procedures established?

Sources of data analyzed to identify

nonconforming product and qualityproblems?

Statistical analysis across data

sources? Investigations conducted to identify root

cause of failures?


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What does FDA look for in the Corrective

and Preventive Action Subsystem?

Nonconforming product controlled?

Appropriate corrective actions and

preventive actions carried out?

Those responsible are told about CAPA

activities?

Management review of CAPA activities?


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What does FDA look for in the Production

and Process Control Subsystem?

Processes are controlled and

monitored?

Any rejects or nonconforming

product?

Equipment adjusted, calibrated andmaintained?


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What does FDA look for in the Production

and Process Control Subsystem?

Manufacturing processes validated

or fully verified?

Software validated?

Production employees trained and

qualified?


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What about the other subsystems?

The other three subsystems are covered

through links with the four main

subsystems:Records, documents and change control

Facility and equipment control

Material control


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What happens at the end of the

inspection?The investigator will:

Meet with management to discuss the

inspection

Present the FDA 483 list of

observations of any

significant deficiencies

Discuss the deficiencies


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What should the manufacturer do

after the inspection?Send a letter to FDA identifying how they

have corrected deficiencies or will correct

them

Provide documentation of any corrections

that have been completed

Provide a timetable or estimatedcompletion date for future corrections


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Where should I send the letter?

Office of Compliance

Center for Devices and Radiological

Health (CDRH)Food and Drug Administration

2094 Gaither Road, HFZ-300

Rockville, Maryland 20850U.S.A.


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Center for Devices & Radiological Health

Office of the

Center Director

Office of Device

Evaluation

Office ofIn Vitro Diagnostic

Device Evaluation & Safety

Office of

Compliance

Office of Surveillance

& Biometrics

Office of Science

& Technology

Office of Systems

& Management

Office of Health &

Industry Programs

Division of Small Manufacturers,

International & Consumer Assistance


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Office of Compliance

Division of Enforcement A

Dental, ENT &

Ophthalmic Devices

OB/GYN, Gastro &

Urology Devices

General Hospital

Devices

General Surgery

Devices

Division of Enforcement B

Cardiovascular &

Neurological Devices

Diagnostic X-ray

Devices

Electronic Products &

Devices

Orthopedic, Physical

Medicine &

Anesthesiology Devices


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What happens next?

Investigator writes an Establishment Inspection

Report or EIR

EIR is sent to the Office of Compliance, Centerfor Devices and Radiological Health (CDRH)

Inspection is classified based on inspectional

findings

Office of Compliance reviewer writes Warning

Letter for inspection classified OAI


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How does FDA classify inspection

reports?NAI No action indicated

VAI Voluntary action indicated some

deficiencies identified but not serious

OAI Official action indicated

serious deficiencies identified,

and FDA must take action to

assure correction


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What actions can FDA take to

addressO

AI inspections?For device manufacturers

outside the U.S.:

Warning Letter

Warning Letter +

Automatic Detention


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Warning Letter

FDA sends Warning Letter

describing manufacturers violations

of FDA regulations and requesting areply within 15 days


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Warning Letter + Automatic Detention

FDA sends Warning Letter describing

manufacturers violations of FDA

regulations and requesting a reply within

15 days

Manufacturers products

are put on automatic

detention to prevent

them from entering the U.S.


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What will the Warning Letter say

about Automatic Detention?

Given the serious nature of these violations ofthe Act, all products manufactured at thisfacility may be detained without physical

examination upon entry into the UnitedStates. In order to prevent your devices frombeing detained without physical exam, yourfirm will need to respond to this WarningLetter (as set forth below) and correct the

violations noted in this letter. In addition, theagency usually needs to conduct a follow-upinspection to verify that the appropriatecorrections have been implemented.


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How do I get my devices off

automatic detention?Submit documentation to FDA showing

that deficiencies have been corrected

FDA will inspect you to confirm that

corrections are adequate before lifting

automatic detention


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Where can I get more information about

FDA inspections and regulations?

QSIT:

http://www.fda.gov/ora/inspect_ref/igs/qsit/QSI

TGUIDE.PDF

http://www.fda.gov/ora/inspect_ref/igs/qsit/qsit

guide.htm

Inspections of Medical Device Manufacturers

Compliance Program 7382.845:

http://www.fda.gov/ora/cpgm/default.htm#devi

ces More . . .


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Quality system regulation:

http://www.accessdata.fda.gov/scripts/cdrh/cf

docs/cfcfr/CFRSearch.cfm?CFRPart=820

General quality system info:

http://www.fda.gov/cdrh/devadvice/32.html

Investigations Operations Manual:

http://www.fda.gov/ora/inspect_ref/iom/default

.htm

More . . .


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Other medical device regulations:

http://www.fda.gov/cdrh/devadvice/

Division of Small Manufacturers, Internationaland Consumer Assistance - E-mail:

[email protected]

Christine Nelson E-mail: [email protected]


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Summary

Quality System Inspection Technique (QSIT)

How FDA conducts inspections

What should a manufacturer do after aninspection

Warning Letter or Warning Letter + Automatic

Detention

Where to go for more information