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Mylan’s PR Plant Gets Warning Letter

Cites failure to comply with manufacturing rules

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has issued a warning letter to Mylan, Inc. for “significant violations” of manufacturing rules at its Caguas, PR manufacturing plant. In a warning letter dated October 13th, the FDA cited the failure to complete a required test meant to ensure uniformity of the medicine content. The letter also said the company failed to fully investigate the failure of a batch or its components to meet required specifications.   In a statement, Mylan spokeswoman Nina Devlin said the company ...

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