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High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

May 10th, 2015

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The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing.

At the University of Georgia (UGA)/FDA International GMP Conference held in Athens, GA in March, OC Office of Manufacturing Quality (OMQ) Director Tom Cosgrove highlighted the percentage of foreign inspections drawing FDA’s “official action indicated” (OAI) rating and explored the implications for pharma companies who are making manufacturing outsourcing and purchasing decisions overseas.

In India, FDA has been conducting unannounced inspections (IPQ April 28, 2014), and the failure rate there has been running at 35%, he noted.

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