Expansive FDA Inspection Powers Reaffirmed with Limits

May 9, 2019 | FDA, FDA Inspection, Inspection, Warrant

Bill Donovan recently wrote the Food and Drug Administration’s (FDA) vast and extensive inspection powers were reaffirmed by a Pennsylvania court. Ruling on the “inspection warrant”  the court ruled that the FDA maintains the authority to secure court ordered warrant to search a drug maker’s (or [possibly a clinical investigator premise) facilities as well as the computers within the facilities without evidencing that a crime has been committed; this represents a much lower standard for the agency than evidence in standard criminal cases.

The court also rules that in this inspection warrant scenario (where the FDA legally forces its way into the facilities and accesses computers using this type of warrant), the premise owners have the legal option to not answer any questions—even not to disclose passwords. The court reaffirms that the FDA has the right to use what it called an “administrative search warrant.”  This case originated from The case is: In the Matter of Administrative Establishment Inspection of: Spa & Organic Essentials of Pennsylvania, No. 1:18-MC-546, 2019 U.S. Dist. LEXIS 65476 (M.D. Pa. Apr. 17, 2019).


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