Impax Still Needs To Fix Production Plant Issues, FDA Says

Law360, New York (March 5, 2013, 4:52 PM EST) -- A U.S. Food and Drug and Administration inspection has again found problems with Impax Laboratories Inc.'s California manufacturing plant, potentially further delaying Impax's proposed Parkinson's disease treatment Rytary, the drugmaker announced Monday.

According to Impax, the FDA had sent it a so-called Form 483 observation report, outlining 12 outstanding manufacturing practices issues exposed by the agency's reinspection of Impax's Hayward, Calif., production plant, which was required after an earlier inspection turned up allegedly lax testing practices at the facility. Three of the alleged issues were related...
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