Drugs From Firms Which Have Not Met Drug GMPs

Why FDA issued it

NOTE: The revision to this import alert dated July 15, 2025, updates the name of alert, reason for alert, guidance section, program and center contacts and PAC code. Changes are noted and bracketed by three asterisks (***). ***As part of FDA's activities intended to protect the health and safety of US consumers, FDA performs foreign inspections and remote regulatory assessments of pharmaceutical establishments engaged in the manufacture, processing, packing, or holding of drugs or drug products intended for sale in the US. Detention without physical examination may be appropriate when information has revealed that a firm is not operating in conformity with current good manufacturing practice requirements (CGMP). In part, the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 201(g)(1) defines "drug" as �(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or

Quoted from the “Reason for Alert” section of the FDA page for 66-40, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.