Under the Federal Food, Drug and Cosmetic Act (FFDCA) and Public Health Service Act, the Food and Drug Administration (FDA) requires sponsors of most FDA-regulated products to submit evidence of their products’ safety in research and/or marketing applications.
The FDA conducts careful inspections of facilities that perform nonclinical laboratory studies to determine compliance with Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) of Title 21 of the Code of Federal Regulations. Nonclinical laboratory studies are experiments in which test articles are studied prospectively in test systems (animals, plants, microorganisms, or subparts thereof) under laboratory conditions to determine their safety.
Please note: The information provided should not be used as a source to compile official counts. Requests for official counts of inspections should be directed to the FDA's Division of Freedom of Information.
Questions and comments regarding nonclinical inspections and the data can be directed by email to GLPQuestions@fda.hhs.gov
NonClinical Labs Inspected under GLP Data Sets
- Archive - NonClinical Labs List from 10/1/1989 through 9/30/2000
- Active - NonClinical Labs List from 10/1/2000 through 3/31/2014
- 1987 Final Rule - Good Laboratory Practice Regulations
- 1984 Proposed Rule -- Good Laboratory Practice Regulations
- 1981 Questions & Answers - Good Laboratory Practice Regulations (Last modified July 2007)
- Bioresearch Monitoring GLP Compliance Program, 2001
- District Names and Abbreviations
- Inspection Classification Definitions
- Inspection Project Area Listings