cGMPs / Facilty Design & Management

Think Like an FDA Inspector: Study the Manual

The best way to understand any FDA inspector's perspectives and what they're looking for when they enter your facility is to study inspections as they do, using FDA's official Investigations Operations Manual. Chapters 5, 7 and 8, on site inspections, recalls and investigations will be especially useful. But even Chapter 1, with official dos and don'ts will offer insights into why inspectors may react or interact with you as they do. A must read, courtesy of FDA's web site.

By U.S. Food and Drug Administration (FDA)

Editor's Note: FDA's Investigations Operations Manual consists of eight chapters, an index and an appendix. Below is a Table of Contents containing links to each chapter/section, and specifying the number of pages and size of each document. All documents are in PDF format; you will need Adobe Acrobat Reader to download these files.

  1. Chapter 1: Administration
  2. (32 pages, 775 KB)

  3. Chapter 2: Regulatory
  4. (37 pages, 1,016 KB)

  5. Chapter 3: Federal and State Cooperation
  6. (28 pages, 758 KB)

  7. Chapter 4: Sampling
  8. (96 pages, 2,956 KB)

  9. Chapter 5: Establishment Inspection
  10. (101 pages, 3,198 KB)

  11. Chapter 6: Imports
  12. (23 pages, 755 KB)

  13. Chapter 7: Recall Activities
  14. (12 pages, 430 KB)

  15. Chapter 8: Investigations
  16. (55 pages, 3,718 KB)

  17. Index
  18. (18 pages, 1,843 KB)

  19. Appendix
  20. (9 pages, 273 KB)

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