June 6, 2011 / 2:40 PM / 6 years ago

Impax gets FDA warning letter, shares fall

2 Min Read

(Reuters) - Impax Laboratories Inc (IPXL.O) said it received a warning letter from U.S. health regulators on deficient sampling and testing of drugs at its Hayward, California-based plant, sending the specialty pharmaceuticals company's shares down 6 percent.

"The warning letter does not affect Impax's manufacturing and shipment of approved products, but could cause FDA to withhold approval of pending applications originating from the Hayward facility," Wells Fargo Securities analyst Michael Tong wrote in a note to clients.

Tong does not expect the warning letter to have a long-term effect on the company's ability to secure approvals, but said near-term revenue could be hurt as production level was scaled back in the second quarter.

The U.S. Food and Drug Administration, which inspected the plant between December 13, 2010 and January 21, 2011, 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.

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 ongoing research and development.

Shares of the company were down 5 percent at $24.37 on Monday on Nasdaq. They earlier touched a low of $24.16.

Reporting by Anand Basu in Bangalore; Editing by Joyjeet Das and Don Sebastian

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