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        Inspection References

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                Quality Systems


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Biotechnology
	Computer Issues
	Devices
	Drugs
	Foods & Cosmetics
	MiscellaneousNote: 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

Biotechnology Inspection Guide (11/91)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 ManufacturersDrugs

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

Aseptic Processing and Packaging for the Food Industry
	Cosmetic Product Manufacturers
	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)
	Guide to Traceback of Fresh Fruit and Vegetables Implicated in Epidemiological InvestigationsMiscellaneous

Foreign Medical Device Manufacturers (9/95)
	Foreign Pharmaceutical Manufacturers (5/96)

                                                                                  Content current as of:
      06/30/2022Inspection Guides                
                          

                        Quality Systems


                        Inspection Technical Guides
 
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