FDA Issues Warning to Impax Labs

The U.S. Food and Drug Administration issued a warning to generic drug maker, Impax Laboratories, Inc., regarding manufacturing practices in its Hayward, California pant. During a review conducted between Dec 13 and Jan 21, FDA inspectors identified problems with Impax’s sampling and testing procedures, as well as the process by which the company determines which manufacturing batches do not meet quality specifications.

As a result of the FDA’s inspection, Impax recalled five production lots of its cholesterol drug, fenofibrate, in March. Moreover, following the inspection and the subsequent warning letter, Impax issued a statement citing the company will work to address all of the FDA’s concerns. While the warning letter does not affect the company’s ability to make and ship products, it does potentially slow any marketing practices based out of the Hayward plant.

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