FDA WARNING_LETTER - Agila Specialties Private Limited - June 27, 2013

The FDA issued a Warning Letter to Agila Specialties Private Limited, Specialty Formulation Facility (SFF) in Bangalore, India, following a June 2013 inspection that revealed significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 210 and 211), rendering their drug products adulterated. The firm's response was deemed insufficient. Key violations include failure to establish and follow procedures to prevent microbiological contamination of sterile products, such as using non-integral gloves and inadequate media fill studies (21 CFR 211.113(b)). Deficiencies were also noted in environmental monitoring systems (21 CFR 211.42(c)(10)(iv)), facility controls to prevent contamination (21 CFR 211.42(c)), and thorough investigation of discrepancies (21 CFR 211.192), which was a repeat observation. Further issues involved inadequate laboratory controls for stability testing (21 CFR 211.160(b)), lack of appropriate computer system controls for data integrity (21 CFR 211.68(b)), and failure to maintain buildings in a sanitary condition, including mold in cold storage (21 CFR 211.56(a)). These extensive deficiencies indicate a lack of effective quality management and understanding of microbial controls. The FDA requires comprehensive corrective actions, including revised procedures, new media fill data, and retrospective evaluations, with potential consequences including withholding new drug approvals and refusal of product admission into the U.S.