FDA Issues Impax Lab with a Form 483 for its Californian Manufacturing Facility

Impax Laboratories, Inc. has announced that FDA performed a re-inspection of the company's Hayward, California manufacturing facility from 16 June to 31 July 2014. At the conclusion of the inspection, FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.

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. Impax says it is working diligently to address FDA's observations and will respond to them within 15 days of receipt of the Form 483.

"Addressing these latest observations and advancing our quality improvement initiatives are our top priorities," said Fred Wilkinson, President and CEO of Impax Laboratories. "Our dedicated teams are focused on creating a world class quality organisation."

"While the past week has been challenging, I remain enthusiastic about Impax's future and the opportunities ahead of us. We have a track record of development and commercialisation success, and a strong pipeline of pending products. In addition, we have the financial resources and balance sheet to create new revenue sources through internal and external development, while pursuing strategic and accretive M&A opportunities."

Impax 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.