FDA WARNING_LETTER - Centaur, Inc. - June 26, 2009

The FDA issued a Warning Letter to Centaur, Inc. following an inspection from June 17-26, 2009, at their Olathe, KS facility. The inspection revealed numerous violations of current Good Manufacturing Practice (cGMP) regulations, specifically 21 C.F.R. Parts 210 and 211, rendering their drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act. Key deficiencies included the failure to maintain written records of investigations into unexplained discrepancies (21 C.F.R. 211.192), inadequate employee education and training documentation (21 C.F.R. 211.25(a)), and lack of a second person's review for accuracy and completeness of original records (21 C.F.R 211.194(a)(8)). Additionally, the firm failed to follow written quality control unit procedures (21 C.F.R. 211.22(d)), properly identify and control rejected in-process materials (21 C.F.R. 211.110(d)), and provide adequate equipment for humidity and temperature control in the warehouse, critical for drug products requiring controlled storage (21 C.F.R. 211.46(b)). The FDA noted these issues indicate serious problems in the firm's quality assurance and laboratory systems, with some observations being repeat violations from prior inspections in 2003, 2005, and 2007. Centaur, Inc. must promptly investigate and correct these violations, providing a detailed response within fifteen working days outlining corrective actions, recurrence prevention plans, and quality system changes. Failure to comply could lead to regulatory actions like seizure or injunction, and impact federal contract awards. The FDA acknowledged the firm's initial response but requested more specific documentation.