FDA Approach To Auditing

U.S.
FDA Approach to Auditing Including QSIT

Christine Nelson Center for Devices & Radiological Health Food & Drug Administration
25 Sept. 2003 Frankfurt, Germany 1
FDA-Speak Terms
Inspection = Audit Investigator = Auditor
25 Sept. 2003
Frankfurt, Germany
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
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

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

What is high priority for inspection?

Device manufacturers that:
Make Make
class III devices
implantable devices and life supporting and life sustaining devices introduced a new device to the market
Recently Have
had significant violations in the

Frankfurt, Germany 6
past
25 Sept. 2003
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 preinspection review

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) notice of inspection explaining FDAs legal authority to inspect (only in the U.S.)
Issue
25 Sept. 2003
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

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)
What is QSIT?
www.fda.gov/ora/in spect_ref/igs/qsit/q sitguide.htm
FOO D AND DR UG ADMINISTRATION
GUIDE TO INSPECTIONS OF QUALITY SYSTEMS
August 1999
25 Sept. 2003
Frankfurt, Germany
11
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

What are the four main subsystems?

Corrective & Preventive Actions
Design Controls
Production & Process Controls
Management Material Controls Equipment & Facility Controls
Records, Documents, & Change Controls

Frankfurt, Germany
25 Sept. 2003
13
What does FDA look for in the Management Subsystem?

Quality Policy established? Management representative
appointed?
Management reviews conducted?
25 Sept. 2003
Frankfurt, Germany
14
What does FDA look for in the Management Subsystem?

Quality audit procedures
established and quality audits conducted?

Quality plan established? Quality system procedures
established?
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?
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?
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?
25 Sept. 2003
Frankfurt, Germany
18
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?
25 Sept. 2003
Frankfurt, Germany
19
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?
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?
25 Sept. 2003
Frankfurt, Germany
21
What about the other subsystems?

The other three subsystems are covered
through links with the four main subsystems:

Records, Facility
documents and change control
and equipment control control
Material
25 Sept. 2003
Frankfurt, Germany
22
What happens at the end of the inspection?

The investigator will:
Meet
with management to discuss the inspection the FDA 483 list of observations of any significant deficiencies the deficiencies
Present
Discuss
25 Sept. 2003
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

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.
Center for Devices & Radiological Health

Office of the Center Director Office of Device Evaluation Office of Compliance Office of Science & Technology Office of Health & Industry Programs Division of Small Manufacturers, International & Consumer Assistance
25 Sept. 2003
Office of In Vitro Diagnostic Device Evaluation & Safety Office of Surveillance & Biometrics Office of Systems & Management
Frankfurt, Germany
26
Office of Compliance
Division of Enforcement A
Dental, ENT &
Division of Enforcement B
Cardiovascular &
Ophthalmic Devices
OB/GYN, Gastro &
Neurological Devices
Diagnostic X-ray
Urology Devices
General Hospital
Devices
Electronic Products &
Devices
General Surgery
Devices
Orthopedic, Physical
Devices
25 Sept. 2003
Medicine & Anesthesiology Devices

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

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
What actions can FDA take to address OAI inspections?

For device manufacturers
outside the U.S.:

Warning Warning
Letter
Letter + Automatic Detention
25 Sept. 2003
Frankfurt, Germany
30
Warning Letter
FDA sends Warning Letter
describing manufacturers violations of FDA regulations and requesting a reply within 15 days
25 Sept. 2003
Frankfurt, Germany
31
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.
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.
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
25 Sept. 2003
Frankfurt, Germany
34
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 . . .

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 . . .

Other medical device regulations:
http://www.fda.gov/cdrh/devadvice/
Division of Small Manufacturers, International
and Consumer Assistance - E-mail: dsma@cdrh.fda.gov

Christine Nelson E-mail: mcn@cdrh.fda.gov
25 Sept. 2003
Frankfurt, Germany
37
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

FDA Approach To Auditing

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U.S.

FDA Approach to Auditing Including QSIT

Why does FDA inspect device manufacturers?

Who conducts inspections for FDA?

Offices around the U.S.

Assessment Bodies in the European Union (EU)

independent third parties accredited by FDA

How does FDA decide who to inspect?

manufactures devices for distribution in the U.S.

gives higher risk devices/situations a higher priority

What is high priority for inspection?

class III devices

had significant violations in the

Does FDA notify the manufacturer of an upcoming inspection?

5 days before the inspection

months in advance to schedule inspection

System Manual or equivalent for preinspection review

What happens when the FDA investigator arrives at the site?

to see the top management

What happens during the inspection?

decide how to organize the inspection

What happens next?

GUIDE TO INSPECTIONS OF QUALITY SYSTEMS

evaluate and states the purpose and importance of each subsystem

objectives to cover during inspection

of records for review

What are the four main subsystems?

Production & Process Controls

Management Material Controls Equipment & Facility Controls

Records, Documents, & Change Controls

What does FDA look for in the Management Subsystem?

What does FDA look for in the Management Subsystem?

established and quality audits conducted?

What does FDA look for in the Design Control Subsystem?

What does FDA look for in the Design Control Subsystem?

nonconforming product and quality problems?

preventive actions carried out?

What about the other subsystems?

through links with the four main subsystems:

documents and change control

and equipment control control

What happens at the end of the inspection?

What should the manufacturer do after the inspection?

have corrected deficiencies or will correct them

that have been completed

completion date for future corrections

Where should I send the letter?

Center for Devices & Radiological Health

Medicine & Anesthesiology Devices

What happens next?

for Devices and Radiological Health (CDRH)

Letter for inspection classified OAI

How does FDA classify inspection reports?

deficiencies identified but not serious

What actions can FDA take to address OAI inspections?

outside the U.S.:

Letter + Automatic Detention

Warning Letter + Automatic Detention

manufacturers violations of FDA regulations and requesting a reply within 15 days

What will the Warning Letter say about Automatic Detention?

How do I get my devices off automatic detention?

that deficiencies have been corrected

Inspections of Medical Device Manufacturers