Impax Receives a Form 483 for California Facility

The specialty pharmaceutical company Impax Laboratories, Inc. announced that the US Food and Drug Administrationperformed a re-inspection of the company’s Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.

Impax said that 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. The Company is working  to address FDA’s observations and will respond to them within 15 days of receipt of the Form 483.

The issuance of the Form 483 at the company’s Hayward facility follows the issuance of a Form 483 from FDA for the company’s Taiwan facility in July 2014. For that facility, Impax Laboratories received a Form 483 with 10 inspectional observations from the FDA based on a general GMP inspection and a pre-approval Inspection (PAI) at the company’s manufacturing facility in Taiwan for Rytar, an investigational extended-release capsule formulation of carbidopa and levodopa for the treatment of idiopathic Parkinson’s disease. The Taiwan facility was approved for product manufacturing by the in September 2009 and by the Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States.The company has also not been informed by the of the impact this Form 483 may have on Rytary’s October 9, 2014 review date under the Prescription Drug User Fee Act (PDUFA).

Source: Impax Laboratories

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