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August 4, 2014
08:31 EDTIPXLImpax reports FDA re-inspected its manufacturing facility in California
Impax Laboratories announced that the FDA performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these observations and, pursuant to its established regulatory process, will defer classification until it has reviewed the Company's response to the inspection.
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