Expert Says FDA Under No Obligation to Educate Companies on Inspection Rights

The FDA has no obligation to educate companies about what is and isn’t fair game during an inspection and there is no equivalent of a “Miranda warning” that cops must give when detaining individuals, says inspections expert David Chesney, principal of DL Chesney Consulting.

The scope of any FDA inspection is governed by law, section 704 of the Federal Food, Drug, and Cosmetic Act, and the agency must issue a Notice of Inspection (FDA Form 482) and display credentials to the “owner, operator or agent in charge” under the law, explained Chesney to FDAnews, noting that, as a rule, the FDA will accept whoever claims to be the agent in charge.

The law permits the FDA to “enter and inspect,” Chesney continued, divulging that this is why the FDA has deemed remote regulatory assessments to not be “inspections” since there is no actual entry by agency personnel. The law also specifies what the FDA has lawful access to, he says, which varies by industry — drugs, devices or food — but for the pharmaceutical industry, this includes drug manufacturing records.

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