FDA Inspection Guides

By GCS (LinkedIn and Twitter)

FDA Guidance 500x500FDA Guide to Inspections of the Following.

  • Biotechnology
  • Computer Issues
  • Devices
  • Drugs
  • Foods Cosmetics
  • Miscellaneous

Note: These documents are reference material for investigators and other FDA personnel.

The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s).

An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both.

FDA Inspection Guide for Biotechnology

FDA Inspection Guide for Computer Issues

FDA Access to a Firm’s Audit Results
The agency’s policy relative to the review of quality audit results is stated in CPG 7151.02. This policy prohibits FDA access to a firm’s audit results. Under the QS/GMP, this prohibition extends to reviews of supplier audit reports and management reviews. However, the procedures and documents that show conformance with 21 CFR 820.50, Purchasing Controls, and 21 CFR 820.20(3)(c), Management Reviews, are subject to FDA inspection.

FDA Inspection Guide for Foods & Cosmetics

FDA Inspection Guide for Miscellaneous

FDA Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

 

Last Date Updated on December 24, 2014