At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.
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 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 chief executive officer of Impax Laboratories. "Our dedicated teams are focused on creating a world class quality organization."
"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 commercialization 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."