FDA Performs Inspection Of Impax Labs.'s Taiwan Facility - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA performed a general GMP inspection and a Pre-Approval Inspection for RYTARYTM at Impax Laboratories, Inc.'s (IPXL) Taiwan manufacturing facility from July 21 to July 26, 2014. As a result of the inspection, the FDA issued a Form 483 with 10 inspectional observations.

The Taiwan facility, which was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010, currently manufactures 12 products for distribution in the U.S.

The FDA did not provide any status or classification to these observations and, as is normal practice, would wait until they have received and reviewed the firm's response to provide this data. Also, the company has 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.

"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.