Regulatory Focus™ > News Articles > Warner Chilcott Warned by FDA for CGMP Violations in Birth Control Product

Warner Chilcott Warned by FDA for CGMP Violations in Birth Control Product

Posted 14 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) sent pharmaceutical manufacturer Warner Chilcott a warning letter 8 March for perceived violations of current good manufacturing practices (cGMPs) at their Fajardo, Puerto Rico plant.

In the letter, FDA notes pharmaceuticals manufactured at the plant were adulterated as a result of staff failing to investigate batch failures and out-of-specification components. Further, the plant was unable to verify whether adulterated batches had been distributed.

FDA found that seven lots of Ovcon, an oral contraceptive product, failed to meet specification, and FDA was concerned stability data did not support the given expiration date.

"[Y]our quality control unit has failed to exercise its responsibility to assure that your product meets its predetermined specifications throughout its shelf life," said FDA. "Significantly, your firm failed to identify the root cause of the problem and has been unable to implement appropriate corrective and preventive actions."


Read more:

Warning Letter - Warner Chilcott Company, LLC 3/8/12


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