FDA WARNING_LETTER - Impax Laboratories, Inc - January 21, 2011

The FDA issued a Warning Letter to Impax Laboratories, Inc. following a December 2010 to January 2011 inspection of their Hayward, CA pharmaceutical manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Parts 210 and 211, rendering their drug products adulterated per 21 U.S.C. § 351(a)(2)(B). The firm's February 2011 response was deemed insufficient. Key violations include the failure to establish written procedures for monitoring and validating manufacturing processes responsible for variability in in-process material and drug product, specifically regarding Fenofibrate 200mg capsule weight variations and unsupported temperature ranges for Colestipol Hydrochloride 1g tablet granulation (21 CFR § 211.110(a)). Additionally, the firm failed to thoroughly investigate batch failures, such as widespread metal contamination in various drug products, and extend investigations to other affected batches (21 CFR § 211.192). This latter issue was a repeat observation, indicating ineffective corrective actions. Impax Laboratories must promptly correct these violations. They are required to provide a written response within fifteen working days detailing specific corrective steps, preventative measures, and supporting documentation. Failure to comply may result in legal actions like seizure and injunction, impact federal contracts, and lead to the withholding of export certificates or denial of pending drug applications. FDA will re-inspect to verify corrections.