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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 will work closely with the FDA to fully address the letter “and believe we will be able to address this matter expeditiously.” She said production at the plant continues.

The only drug discussed in the letter was a generic version of the anti-diarrhea medicine commonly known by the brand name Imodium. 

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