US FDA Guidance On Interference With Inspections Needs More Detail, Attorneys Say

Agency should clarify how quickly it expects requested documents to be produced before a company is determined to have delayed an inspection, attorneys say during a FDLI meeting discussion of how a 2012 law enabling the agency to put a foreign facility on import alert for delaying, limiting, or refusing an inspection has played out.

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The US FDA should clarify the “gray areas” of its four-year-old guidance governing the circumstances under which a drug manufacturer could be considered to be delaying, denying, limiting or refusing a facility inspection, industry attorneys say.

It would help manufacturers and facility owners to get a better idea of FDA’s expectations, such as how quickly agency inspectors should receive documents requested during an inspection before characterizing...

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