FDA's Kopcha Says New Inspection Protocols May Never Be Disclosed

 
• By Bowman Cox

Head of US FDA's Office of Pharmaceutical Quality says agency doesn't want pharmaceutical companies to know just how they will be inspected under the emerging standardized 'NIPP' approach, lest they use that knowledge to game the process.

Swabbing of glove box
FDA investigators swab glovebox during a recent pharmacy inspection • Source: US Justice Department

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