FDA WARNING_LETTER - UNAM, Facultad De Estudios Superiores Cuautitlan - September 14, 2011

An FDA inspection conducted from September 13-14, 2011, at UNAM, Facultad De Estudios Superiores Cuautitlan, a contract testing laboratory in Cuautitlan Izcalli, Mexico, identified significant deviations from Current Good Manufacturing Practice (CGMP) for the testing of active pharmaceutical ingredients (APIs). These deviations render the tested APIs adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA expressed concern over a general lack of CGMPs, particularly in documentation and record retention. Specific violations included incomplete laboratory records, lack of routine calibration and qualification for critical laboratory instrumentation, improper handling and storage of secondary reference standards, absence of a written procedure for investigating out-of-specification results, and inadequate employee training on job functions and CGMPs. The firm's initial response to the Form FDA 483 was not considered due to late submission but will be evaluated as a direct response to this Warning Letter. The FDA recommends seeking a third-party consultant for a comprehensive CGMP evaluation. The firm must provide a written response within fifteen working days detailing corrective actions, including specific remediation plans for each observation, and evidence of implementation. Failure to correct these deviations may result in the FDA withholding approval of new applications listing the firm as a contract testing laboratory.