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FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.
Impax Laboratories announced that FDA has issued a Form 483 with three inspectional observations, none of which were designated as repeat observations, following a three-week inspection of the company’s Hayward, CA manufacturing facility. The inspection included a general GMP as well as pre-approval inspections (PAI) for multiple generic products currently pending approval at the FDA.
“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 chief executive officer of Impax Laboratories in a company press release. "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."
Source: Impax Laboratories