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FDA Investigators Want Top Management Involved In Manufacturing Inspections

 
• By Joanne S. Eglovitch

FDA’s expectation is that the most responsible individual at manufacturing sites be involved in inspections. The agency is increasingly talking about its “responsible corporate official” or Park Doctrine powers to hold top officials responsible for manufacturing issues and problems.

Closeup of gavel in court room

FDA investigators expect to see top corporate officials present during inspections or if they cannot be there, to sign a Form 482 indicating their awareness that an inspection is taking place. This is occurring as the agency is increasingly talking about its ‘responsible corporate officer” or Park Doctrine powers to hold top officials responsible for manufacturing problems.

FDA is also insisting on holding top corporate officials accountable by having their signatures on consent decrees, even if they...

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