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25 Sept. 2003 Frankfurt, Germany1 U.S. FDA Approach to Auditing Including QSIT Christine Nelson Center for Devices & Radiological Health Food & Drug Administration.

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Presentation on theme: "25 Sept. 2003 Frankfurt, Germany1 U.S. FDA Approach to Auditing Including QSIT Christine Nelson Center for Devices & Radiological Health Food & Drug Administration."— Presentation transcript:

1 25 Sept Frankfurt, Germany1 U.S. FDA Approach to Auditing Including QSIT Christine Nelson Center for Devices & Radiological Health Food & Drug Administration

2 25 Sept Frankfurt, Germany2 FDA-Speak Terms Inspection = Audit Investigator = Auditor

3 25 Sept Frankfurt, Germany3 Why does FDA inspect device manufacturers? To evaluate compliance with the following FDA device regulations: Quality Systems Medical Device Reporting Medical Device Tracking Reports of Corrections and Removals Registration and Listing

4 25 Sept Frankfurt, Germany4 Who conducts inspections for FDA? 1. FDA investigators in 20 FDA District Offices around the U.S. 2. FDA-trained Auditors from Conformity Assessment Bodies in the European Union (EU) 3. In the future, FDA-trained auditors from independent third parties accredited by FDA

5 25 Sept Frankfurt, Germany5 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 and gives higher risk devices/situations a higher priority

6 25 Sept Frankfurt, Germany6 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

7 25 Sept Frankfurt, Germany7 Does FDA notify the manufacturer of an upcoming inspection? FDA calls domestic manufacturers about 5 days before the inspection FDA contacts foreign manufacturers months in advance to schedule inspection Manufacturer is requested to send Quality System Manual or equivalent for pre- inspection review

8 25 Sept Frankfurt, Germany8 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 explaining FDAs legal authority to inspect (only in the U.S.)

9 25 Sept Frankfurt, Germany9 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 organize the inspection

10 25 Sept Frankfurt, Germany10 What happens next? The investigator will: Ask about size and structure of company, who is in charge, what products are manufactured there Review registration and listing Evaluate compliance with FDA regulations using the Quality System Inspection Technique (QSIT)

11 25 Sept Frankfurt, Germany11 What is QSIT? spect_ref/igs/qsit/q sitguide.htm

12 25 Sept Frankfurt, Germany12 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 advice Provides tables for statistical sampling of records for review

13 25 Sept Frankfurt, Germany13 What are the four main subsystems? Design Controls Material Controls Records, Documents, & Change Controls Equipment & Facility Controls Production & Process Controls Corrective & Preventive Actions Management

14 25 Sept Frankfurt, Germany14 What does FDA look for in the Management Subsystem? Quality Policy established? Management representative appointed? Management reviews conducted?

15 25 Sept Frankfurt, Germany15 What does FDA look for in the Management Subsystem? Quality audit procedures established and quality audits conducted? Quality plan established? Quality system procedures established?

16 25 Sept Frankfurt, Germany16 What does FDA look for in the 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?

17 25 Sept Frankfurt, Germany17 What does FDA look for in the Design Control Subsystem? Software validation completed? Risk analysis carried out? Design reviews conducted? Design transfer to manufacturing completed successfully?

18 25 Sept Frankfurt, Germany18 What does FDA look for in the Corrective and Preventive Action Subsystem? CAPA procedures established? Sources of data analyzed to identify nonconforming product and quality problems? Statistical analysis across data sources? Investigations conducted to identify root cause of failures?

19 25 Sept Frankfurt, Germany19 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?

20 25 Sept Frankfurt, Germany20 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 and maintained?

21 25 Sept Frankfurt, Germany21 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?

22 25 Sept Frankfurt, Germany22 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

23 25 Sept Frankfurt, Germany23 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

24 25 Sept Frankfurt, Germany24 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 estimated completion date for future corrections

25 25 Sept Frankfurt, Germany25 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 U.S.A.

26 25 Sept Frankfurt, Germany26 Center for Devices & Radiological Health Office of the Center Director Office of Device Evaluation Office of In 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

27 25 Sept Frankfurt, Germany27 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

28 25 Sept Frankfurt, Germany28 What happens next? Investigator writes an Establishment Inspection Report or EIR EIR is sent to the Office of Compliance, Center for Devices and Radiological Health (CDRH) Inspection is classified based on inspectional findings Office of Compliance reviewer writes Warning Letter for inspection classified OAI

29 25 Sept Frankfurt, Germany29 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

30 25 Sept Frankfurt, Germany30 What actions can FDA take to address OAI inspections? For device manufacturers outside the U.S.: Warning Letter Warning Letter + Automatic Detention

31 25 Sept Frankfurt, Germany31 Warning Letter FDA sends Warning Letter describing manufacturers violations of FDA regulations and requesting a reply within 15 days

32 25 Sept Frankfurt, Germany32 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.

33 25 Sept Frankfurt, Germany33 What will the Warning Letter say about Automatic Detention? Given the serious nature of these violations of the Act, all products manufactured at this facility may be detained without physical examination upon entry into the United States. In order to prevent your devices from being detained without physical exam, your firm will need to respond to this Warning Letter (as set forth below) and correct the violations noted in this letter. In addition, the agency usually needs to conduct a follow-up inspection to verify that the appropriate corrections have been implemented.

34 25 Sept Frankfurt, Germany34 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

35 25 Sept Frankfurt, Germany35 Where can I get more information about FDA inspections and regulations? QSIT: TGUIDE.PDF TGUIDE.PDF guide.htm guide.htm Inspections of Medical Device Manufacturers Compliance Program : ces More... ces

36 25 Sept Frankfurt, Germany36 Where can I get more information about FDA inspections and regulations? Quality system regulation: docs/cfcfr/CFRSearch.cfm?CFRPart=820 docs/cfcfr/CFRSearch.cfm?CFRPart=820 General quality system info: Investigations Operations Manual: More...

37 25 Sept Frankfurt, Germany37 Where can I get more information about FDA inspections and regulations? Other medical device regulations: Division of Small Manufacturers, International and Consumer Assistance - Christine Nelson –

38 25 Sept Frankfurt, Germany38 Summary Quality System Inspection Technique (QSIT) How FDA conducts inspections What should a manufacturer do after an inspection Warning Letter or Warning Letter + Automatic Detention Where to go for more information


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