USFDA issues Form 483 to Impax Laboratories Hayward, California manufacturing facility
USFDA has issued Impax laboratories form 483 Hayward facility. Impax on 11th May, 2015 announced that FDA performed a three week inspection of the Company's Hayward, California manufacturing facility. Fred Wilkinson, president and chief executive officer of Impax Laboratories said “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". Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. FDA 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 May 8, the FDA issued a Form 483 with three inspectional observations, none of which were designated as repeat observations.