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U.S. FDA Approach to Auditing Including QSIT

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Title: U.S. FDA Approach to Auditing Including QSIT


1
U.S. FDA Approach to Auditing Including QSIT
  • Christine Nelson
  • Center for Devices Radiological Health
  • Food Drug Administration

2
FDA-Speak Terms
  • Inspection Audit
  • Investigator Auditor

3
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
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
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
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
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 Quality System
    Manual or equivalent for pre-inspection review

8
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
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
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
What is QSIT?
  • www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm

12
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
What are the four main subsystems?
Corrective Preventive Actions
Design Controls
Production Process Controls
Management
Equipment Facility Controls
Material Controls
Records, Documents, Change Controls
14
What does FDA look for in the Management
Subsystem?
  • Quality Policy established?
  • Management representative appointed?
  • Management reviews conducted?

15
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
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
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
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
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
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
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
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
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
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
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 20850
  • U.S.A.

26
Center for Devices Radiological Health
27
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
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
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
What actions can FDA take to address OAI
inspections?
  • For device manufacturers outside the U.S.
  • Warning Letter
  • Warning Letter Automatic Detention

31
Warning Letter
  • FDA sends Warning Letter describing
    manufacturers violations of FDA regulations and
    requesting a reply within 15 days

32
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
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
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
Where can I get more information about FDA
inspections and regulations?
  • QSIT
  • http//www.fda.gov/ora/inspect_ref/igs/qsit/QSITGU
    IDE.PDF
  • http//www.fda.gov/ora/inspect_ref/igs/qsit/qsitgu
    ide.htm
  • Inspections of Medical Device Manufacturers
    Compliance Program 7382.845 http//www.fda.gov/or
    a/cpgm/default.htmdevices More . . .

36
Where can I get more information about FDA
inspections and regulations?
  • Quality system regulation http//www.accessdata.f
    da.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFR
    Part820
  • General quality system info http//www.fda.gov/cd
    rh/devadvice/32.html
  • Investigations Operations Manual
    http//www.fda.gov/ora/inspect_ref/iom/default.htm
    More . . .

37
Where can I get more information about FDA
inspections and regulations?
  • Other medical device regulations
    http//www.fda.gov/cdrh/devadvice/
  • Division of Small Manufacturers, International
    and Consumer Assistance - E-mail
    dsma_at_cdrh.fda.gov
  • Christine Nelson E-mail mcn_at_cdrh.fda.gov

38
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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