New 483 Gums Up Impax Pipeline, Adds to Hayward Remediation Pain
Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.
Speaking on a conference call to discuss the company’s first-quarter results, Impax President and CEO Larry Hsu declined to provide details about the deficiencies but said there were no repeat observations from last year’s warning letter.
Hsu also said the company has not been told by the FDA what impact the latest Form 483 will have on the resolution of the May 31, 2011, warning letter, which found deviations related to sampling and testing of in-process materials and drug products, among other things
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