Impax Laboratories Receives a Form 483 for Taiwan Manufacturing Facility

Impax Laboratories has received a Form 483 with 10 inspectional observations from the US Food and Drug Administration (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. It

The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States.

Impax said that the FDA did not provide any status or classification to these observations and, as is normal practice, the agency will wait until it has received and reviewed the company’s response to provide this information. The company has also not been informed by the FDA of the impact this Form 483 may have on Rytary’s October 9, 2014 review date under the Prescription Drug User Fee Act (PDUFA).

“We are already working diligently to address the observations raised by the FDA and will respond to these observations within the required 15 business day period from the receipt of the Form 483,” said Fred Wilkinson , president and chief executive officer of Impax Laboratories,” in a company statement. “We remain committed to our overarching goal of implementing a world class continuous quality improvement program and maintaining the highest quality standards across our facilities.”

Source: Impax Laboratories



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