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FDA Finds Problems Continue at IMPAX Laboratories, Inc. (IPXL) Factory in Hayward


3/6/2013 8:13:30 AM

The Food and Drug Administration inspected an Impax Laboratories Inc. factory in Hayward in January and February and found a dozen possible problems there, three of them which persist from an earlier inspection in 2011. Results of the inspection are considered "observations" until the FDA makes a final determination based on what its inspectors have seen. In the past, inspectors found problems at the factory and Impax (NASDAQ: IPXL) said the trouble might hold up approvals of some of its drugs as a result. Pending drug applications to the FDA that list the Hayward factory as a manufacturing location could be delayed, the company said in February 2012. These recent inspections, from Jan. 8 through Feb. 28, found potential problems with the way Impax planned to manufacture its drug IPX-066, or Rytary, a formulation of levodopa and carbidopa in a capsule aimed at Parkinson's disease symptoms.


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