Docket Number:
FDA-2016-D-2268
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health . . .” Drug products prepared, packed, or held under insanitary conditions could become contaminated and cause serious adverse events, including death. 

 

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