Nonclinical Laboratories Inspected under Good Laboratory Practices
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 or Office of Media Affairs.
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
The information provided specifically discloses the final inspection classification for inspections conducted of facilities that perform nonclinical laboratory studies. This information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken.