1. PREPARATION FOR FDA INSPECTION
NEMA/ADVAMED/PHILIPS
September 25, 2003
Robert L. Turocy

2. INSPECTION CYCLE
PRE-INSPECTION
INSPECTION
POST-INSPECTION

3. FDA REQUESTS INSPECTION
TELEPHONE CALL
DATE IDENTIFIED
REQUEST FOR DOCUMENTATION
FACILITY CONTACT

4. PRE-INSPECTION PLAN INSPECTION, OBJECTIVES ASSIGN COORDINATOR
INSPECTION SCOPE & REGULATIONS
REVIEW PROCEDURES
REVIEW PAST INSPECTIONS
DOCUMENTATION SUPPLIED
SCHEDULING, PERSONNEL, & FACILITIES PREPARATION
TRAINING

5. PRE-INSPECTION CONT. GENERATE LOG TOP PRIORITY FDA NEEDS
INSPECTION TYPE
INTERPERTER
MOCK INSPECTION

6. PRE-INSPECTION CONT. REVIEW QM & POLICY ACTIVITIES ASSIGNED ALTERNATES
COMMUNICATION

7. FDA ACCESS MEDICAL DEVICE TRAINING RECORDS MATERIALS PACKAGING
LABELING
EQUIPMENT
LOCATION
REGISTRATION & LISTING
FACILITIES

8. FDA ACCESS cont. SAMPLES PRODUCTION RECORDS CHANGE CONTROL
COMPLAINT FILES
SHIPPING RECORDS
DMR
DHR
MDR AND C&R

9. REFUSE FDA ACCESS FINANCIAL DATA SALES VALUES PRICING PERSONNEL DATA
MANAGEMENT REVIEWS
INTERNAL AUDITS
SUPPLIER AUDITS

10. INSPECTION OPENING MEETING REQUEST ID INTRODUCTION SCOPE
DAILY MEETINGS
REVIEW FINDINGS & OBSERVATIONS
CHANGES
CORRECTIONS

11. INSPECTION CONT. CLOSING MEETING ATTENDEES SUMMARY FDA 483
CLARIFY ISSUES
IMMEDIATE CA
VERBAL CORRECTION
CA PLAN
MANAGEMENT

12. POST-INSPECTION ASSIGNEMENTS REVISIONS REPORT TO MGT IMPLEMENT CA
RESPOND TO FDA
FDA RESPONSE

13. POST-INSPECTION cont. FOLLOW-UP OTHER REGULATORY ACTION IMPROVEMENT
EIR

14. INSPECTION DOs DO PLAN FOR INSPECTION
DO PROVIDE REVELANT DOCUMENTATION
DO ANSWER QUESTIONS TO SPECIFIC ACTIVITY
DO ESCORT THE INSPECTOR
DO TAKE NOTES
DO COPY DOCUMENTS REMOVED
DO STAMP THE REMOVE DOCUMENTS
DO COOPERATE WITH THE FDA
BE POLITE BUT FIRM WITH YOUR RIGHTS

15. INSPECTION DON’Ts DON’T OVER SPEAK OR SAY IT’S IMPOSSIBLE
DON’T ALLOW RECORDINGS
DON’T SIGN AFFIDAVITS
DON’T ALLOW ACCESS TO FILES
DON’T GUESS AT AN ANSWER
DON’T ANSWER “WHAT IF ?”
DON’T ENGAGE IN ARGUMENT

16. REFERENCES 21 CFR 820, Preamble & Regulation
INSP. DEVICE MFGRS. CP
FDA QSIT HANDBOOK GUIDE
ADVAMED POINTS TO CONSIDER MGMT, DESIGN, & CAPA