Mylan warned by FDA on testing failures

Mylan ($MYL) CEO Robert Coury (photo) was sent an FDA warning letter in mid-October as a result of a January-February 2011 inspection of a Puerto Rico plant. The letter, which was just posted to the FDA website, contains just two counts.

The first GMP violation involved pre-release confirmation that a manufactured product conformed to specs. The letter said the company lacked "appropriate laboratory determination" of conformance for each product batch.

For example, the letter said Mylan failed to complete a content uniformity test--a USP requirement--after loperamide hydrochloride capsules flunked conformance testing. In addition, in responding to the Form 483 observation about the test, Mylan failed to justify why it had not been completed.   

Mylan's second violation concerned its investigation of batch failures. The letter said that in several investigations, Mylan failed to provide supporting evidence of the causes it cited for out-of-specification results.

- here's Warning Letter 12-SJN-WL-01

Special Report: Fierce's 2011 warning letters report

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