FDA Inspection Guides | Regulatory Doctor
Guide to Inspections of:
- Biotechnology
- Biologics
- 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.
Biotechnology
Biologics
- Source Plasma Establishments (Rev 4/01)
- Infectious Disease Marker Testing Facilities (6/96)
- Viral Clearance Processes for Plasma Derivatives
Computer Issues
- Computerized Systems in Drug Establishments (2/83)
- Computerized Systems in Food Processing Industry
- Glossary of Computer Systems Software Development Terminology (8/95)
Devices
- Quality Systems
- Electromagnetic Compatibility Aspects of Medical Device Quality Systems
- Bioresearch Monitoring Inspections of In Vitro Diagnostics Devices
- Mammography Quality Standards Act Auditor’s Guide
- Medical Device Manufacturers
Drugs
- High Purity Water Systems (7/93)
- Lyophilization of Parenterals (7/93)
- Microbiological Pharmaceutical Quality Control Labs (7/93)
- Pharmaceutical Quality Control Labs (7/93)
- Validation of Cleaning Processes (7/93)
- Dosage Form Drug Manufacturers cGMPs (10/93)
- Oral Solid Dosage Forms Pre/Post Approval Issues (1/94)
- Sterile Drug Substance Manufacturers (7/94)
- Topical Drug Products (7/94)
- Oral Solutions and Suspensions (8/94)
Foods & Cosmetics
- Allergy Inspection Guide (4/01)
- Aseptic Processing and Packaging for the Food Industry
- Nutritional Labeling and Education Act (NLEA) Requirements (8/94 – 2/95)
- Cosmetic Product Manufacturers (2/95)
- Computerized Systems in the Food Processing Industry
- Grain Product Manufacturers
- Guide to Produce Farm Investigations (11/05)
- Interstate Carriers and Support Facilities (4/95)
- Dairy Product Manufacturers (4/95)
- Miscellaneous Food Products – Vol. 1 (5/95)
- Miscellaneous Food Products – Vol. 2 (9/96)
- Low Acid Canned Food Manufacturers Part 1 – Adminstrative Procedures/Scheduled Processes
- Low Acid Canned Food Manufacturers Part 2 – Processes/Procedures
- Low Acid Canned Food Manufacturers Part 3 – Container/Closures (11/98)
- Acidified Food Manufacturers
- Guide to Traceback of Fresh Fruit and Vegetables Implicated in Epidemiological Investigations
- Samonella Enteritidis (SE) Guide to Traceback in Eggs (7/03)
Miscellaneous
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