Industry Worries FDA Will See Drug GMP Violations Captured By Security Cameras
A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.
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COMPETES Act also includes enhanced penalties for drug makers who falsify or destroy records, power for the FDA to recall harmful drugs, funding for drug manufacturing technology and additional supply chain flexibility efforts.
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.
Emcure's Hinjwadi, India, plant should have investigated other more likely sources of contamination more thoroughly, the FDA says.