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U.S. Food and Drug Administration
Protecting and Promoting Your Health Inspection Guides
We have recently redesigned the FDA Web Site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.(/AboutFDA/ContactFDA/default.htm)
Guide to Inspections of:•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.
Page Updated: 2006-05-25
Biotechnology
•Biotechnology Inspection Guide (11/91)
(/ICECI/Inspections/InspectionGuides/ucm074181.htm)
Computer Issues
•Computerized Systems in Drug Establishments (2/83)
(/ICECI/Inspections/InspectionGuides/ucm074869.htm)
•Computerized Systems in Food Processing Industry
(/ICECI/Inspections/InspectionGuides/ucm074871.htm)
•Glossary of Computer System Software Development Terminology (8/95)
(/ICECI/Inspections/InspectionGuides/ucm074875.htm)
Devices
•Quality Systems(/ICECI/Inspections/InspectionGuides/ucm074883.htm)
•Electromagnetic Compatibility Aspects of Medical Device Quality Systems
(/ICECI/Inspections/InspectionGuides/ucm074885.htm)
•Bioresearch Monitoring Inspections in Vitro Diagnostics Devices
(/ICECI/Inspections/InspectionGuides/ucm074893.htm)•Mammography Quality Standards Act Auditor's Guide
(/ICECI/Inspections/InspectionGuides/ucm074895.htm)
•Medical Device Manufacturers(/ICECI/Inspections/InspectionGuides/ucm074899.htm)
Drugs
•High Purity Water System (7/93)(/ICECI/Inspections/InspectionGuides/ucm074905.htm)•Lyophilization of Parenteral (7/93)(/ICECI/Inspections/InspectionGuides/ucm074909.htm)•Microbiological Pharmaceutical Quality Control Labs (7/93)
(/ICECI/Inspections/InspectionGuides/ucm074914.htm)•Pharmaceutical Quality Control Labs (7/93)
(/ICECI/Inspections/InspectionGuides/ucm074918.htm)
•Validation of Cleaning Processes (7/93)(/ICECI/Inspections/InspectionGuides/ucm074922.htm)•Dosage Form Drug Manufacturers cGMPs (10/93)
(/ICECI/Inspections/InspectionGuides/ucm074927.htm)
•Oral Solid Dosage Forms Pre/Post Approval Issues (1/94)
(/ICECI/Inspections/InspectionGuides/ucm074928.htm)
•Sterile Drug Substance Manufacturers (7/94)
(/ICECI/Inspections/InspectionGuides/ucm074930.htm)
•Topical Drug Products (7/94)(/ICECI/Inspections/InspectionGuides/ucm074933.htm)•Oral Solutions and Suspensions (8/94)(/ICECI/Inspections/InspectionGuides/ucm074935.htm)
Foods & Cosmetics
•Allergy Inspection Guide (4/01)(/ICECI/Inspections/InspectionGuides/ucm074944.htm)•Aseptic Processing and Packaging for the Food Industry
(/ICECI/Inspections/InspectionGuides/ucm074946.htm)
•Nutritional Labeling and Education Act (NLEA) Requirements (8/94 - 2/95)
(/ICECI/Inspections/InspectionGuides/ucm074948.htm)
•Computerized Systems in the Food Processing Industry
(/ICECI/Inspections/InspectionGuides/ucm074955.htm)
•Grain Product Manufacturers(/ICECI/Inspections/InspectionGuides/ucm074958.htm)•Guide to Produce Farm Investigations (11/05)
(/ICECI/Inspections/InspectionGuides/ucm074962.htm)
•Interstate Carriers and Support Facilities (4/95)
(/ICECI/Inspections/InspectionGuides/ucm074964.htm)
•Dairy Product Manufacturers (4/95)(/ICECI/Inspections/InspectionGuides/ucm074974.htm)•Miscellaneous Food Products - Vol. 1 (5/95)
(/ICECI/Inspections/InspectionGuides/ucm074967.htm)
•Miscellaneous Food Products - Vol. 2 (9/96)
(/ICECI/Inspections/InspectionGuides/ucm074988.htm)