FDA Performs GMP and Pre-Approval Inspections of Impax's Hayward Facility

Impax Laboratories has announced that FDA performed a 3-week inspection of the company's Hayward, California manufacturing facility. This inspection included a general GMP as well as Pre-Approval Inspections (PAI) for multiple generic products currently pending approval at the FDA. At the conclusion of the inspection on 8 May, the FDA issued a Form 483 with three inspectional observations, none of which were designated as repeat observations.

"While our goal is to have no observations from any inspection at any of our facilities, the agency found additional items for us to focus on which we will promptly respond to within 15 days of the receipt of the Form 483," said Fred Wilkinson, president and CEO of Impax Laboratories. "The fact that the FDA returned to Hayward to perform a GMP and PAI inspections on multiple products was one of the options we had prepared for."

"During this inspection, we were also able to confirm that the July 2014 inspection of our Hayward facility was classified as Voluntary Action Indicated (VAI). The FDA did not provide any status or classification of this current inspection and, pursuant to its established regulatory process, will defer classification until it has reviewed the company's response to each observation. We are committed to and will continue to invest in a quality and compliance program that enables us to continuously strive to exceed expectations across all areas of our business."