Impax Laboratories Inc. announced in a press release that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY at the company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the end of the inspection, the FDA issued a Form 483 with 10 inspectional observations. 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.
The FDA did not provide any status or classification to these observations and, as is normal practice, will wait until they have 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. "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."
The Company has provided a redacted version of the Form 483 as an exhibit in a Current Report on Form 8-K filed with the SEC concurrently with the issuance of this press release.