FDA Inspections, 483’s & Warning Letters How to Avoid and Survive Them
FDA Inspections, 483's & Warning Letters
How to Avoid and Survive Them
Elizabeth L. Hohmann MD Physician Director, Partners IRBs
Sarah A. White MPH Director, Partners QI Program
June 12, 2017
1
Outline
? Overview ? FDA Inspection Process ? Case Studies from FDA 483s & Warning
Letters
? Clinical Investigators ? IRBs
2
FDA Authority
? Authority derived from 21 CFR 312, 812 ? Biomedical Research Monitoring Programming (BIMO),
established in 1977
? Objectives
? To protect the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials;
? To verify the quality and integrity of the research data ? To assess compliance with FDA's regulations governing the
conduct of clinical trials.
3
BIMO Inspections
? Inspection assignments issued by Center to District Office
FDA
? Types of inspections
? Routine/Surveillance
? For Cause
? Announced vs. unannounced inspections
? Compliance Programs
? Clinical Investigators
? Institutional Review Boards
? Sponsors, Monitors & Contract Research Organization
? In-vivo Bioequivalence facilities
? Good Laboratory Practice (Non-Clinical Laboratories)
4
Why would you be inspected?
? Routine inspection:
? Clinical Investigator - verify data submitted to the FDA ? FDA is interested in what you're doing ? IRB: Every 5 years
? For-cause/Directed
? FDA receives information that calls into question study conduct or IRB practices
? Can be limited to one area of concern or cover entire study/ compliance program
5
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