FDA Warns Apotex Management To Demand Quality, Meet Specs
Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.
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Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.
Persistent data integrity and quality unit failures at two Apotex plants in Bangalore, India, led to wholesale US market withdrawals by the Canadian generic drug manufacturer.
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.