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    1. Compliance
    2. cGMPs

    Think Like an FDA Inspector: Study the Manual

    June 14, 2006
    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.
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    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)

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

    3. Chapter 3: Federal and State Cooperation
      4.  (28 pages, 758 KB)

    4. Chapter 4: Sampling
      5.  (96 pages, 2,956 KB)

    5. Chapter 5: Establishment Inspection
      6.  (101 pages, 3,198 KB)

    6. Chapter 6: Imports
      7.  (23 pages, 755 KB)

    7. Chapter 7: Recall Activities
      8.  (12 pages, 430 KB)

    8. Chapter 8: Investigations
      9.  (55 pages, 3,718 KB)

    9. Index
      10.  (18 pages, 1,843 KB)

    10. Appendix
      11.  (9 pages, 273 KB)
    About the Author

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