The U.S. Food and Drug Administration (FDA) is authorized to conduct inspections under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection.” FDA’s authority to request and inspect certain documentation was expanded in connection with the implementation of the current Good Manufacturing Practices (cGMP) for dietary supplements 21 CFR §111. The scope of FDA’s authority to inspect as well as enforce was further expanded with the passage of the Food Safety Modernization Act (FSMA).
How to deal with FDA:
What is a Form FDA 483?
How do I avoid a Warning Letter?
What is a Consent Decree?