Impax gets FDA warning letter for California plant

Impax gets FDA warning letter for California plant

June 6th, 2011 // 2:33 pm @

Impax Laboratories Inc said it received a warning letter from the U.S. health regulators after it inspected the specialty pharmacueticals company’s Hayward, California-based manufacturing facility.

In its letter, the U.S. Food and Drug Administrator cited “deviations from current Good Manufacturing Practice for Finished Pharmaceuticals,” the company said.

The deviations related to sampling and testing of in-process materials and drug products, production record review and the company’s process for probing the failure of some manufacturing batches to meet specifications.

The FDA inspected the plant between December 13, 2010 and January 21, 2011, Impax said.

In March, Impax Laboratories recalled five lots of cholesterol drug Fenofibrate.

The company said the FDA’s observations related to the Hayward manufacturing facility only.

It added that it does not expect the manufacturing setback to delay its ongoing research and development activities.


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