Inspections, Compliance, Enforcement, and Criminal Investigations
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.
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.