FDA 483 - Turbare Manufacturing - May 07, 2026

Between April 20 and May 7, 2026, the FDA conducted an inspection of Turbare Manufacturing, an outsourcing facility located in Conway, Arkansas. The resulting report identifies several critical failures in the firm’s quality control and sterile manufacturing processes. Key violations center on the facility"s inability to maintain a clean environment. Investigators documented over 20 instances of mold and fungal contamination in cleanrooms and repeated bacterial recoveries from staff during monitoring. Despite these recurring issues, the quality unit failed to perform effective root-cause analyses or verify that their corrective measures actually worked. Furthermore, the firm neglected to perform essential airflow studies on equipment used to produce sterile drugs, leaving no assurance that the environment remained protected during operations. The inspection also revealed that the company frequently ignored high failure rates during visual inspections of ophthalmic products. Rather than investigating why syringes contained particles or incorrect fill volumes, the firm simply performed secondary inspections to pass the batches. Under the FDA’s regulatory framework for outsourcing facilities, Turbare Manufacturing must now address these deficiencies. The company is required to respond to the FDA with a comprehensive plan for corrective and preventive actions to ensure the safety and sterility of their drug products.