FDA WARNING_LETTER - Turbare Manufacturing - January 24, 2025

The FDA issued a Warning Letter to Turbare Manufacturing, an outsourcing facility in Conway, Arkansas, following an inspection from January 14 to January 24, 2025. The inspection identified serious deficiencies in the company"s sterile drug production practices, resulting in drug products being classified as adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) due to insanitary conditions and violations of Current Good Manufacturing Practice (CGMP). Key violations included failure to conduct adequate process simulation (media fill) studies, insufficient investigation of discrepancies or batch failures, lack of established acceptance criteria for quality control, and inadequate procedures for preventing microbiological contamination and monitoring environmental conditions in aseptic areas. Turbare Manufacturing initiated a voluntary recall of Bevacizumab due to sterility assurance concerns. The FDA deemed the company"s submitted corrective actions deficient, specifically regarding an investigation into mold contamination and the conduct of media fill studies where cleaning was intentionally omitted. Turbare Manufacturing is required to comprehensively address these serious violations to ensure the safety and quality of its drug products, emphasizing timely investigations and adherence to all procedures, including cleaning, during process simulations.