Court Blesses FDA’s Rarely Used Administrative Search Warrant Authority

By Anne K. Walsh — A recent decision out of Pennsylvania caught our eye, not because it applied a new enforcement strategy by FDA, but to the contrary, because it relied on FDA’s “oldie but goodie” Inspection Warrant authority.  Not a search warrant, which is subject to the same “probable cause” standard as all criminal search warrants, but an administrative tool that is rooted in the inspection provisions of the FDC Act, 21 U.S.C. § 374(a).  FDA admits it rarely uses this authority: “FDA does not routinely request inspection warrants in order to conduct investigations or inspections of regulated industry. However, warrants have been used effectively to gather information that has been refused improperly.” FDA’s Regulatory Procedures Manual requires the following criteria to seek an inspection warrant: FDA is entitled by statute or regulation to inspect the facility and to have access to the information which…

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