FDA 483 - Leesar Inc - July 18, 2025

An FDA inspection conducted at Leesar Inc, a Fort Myers-based repackager/relabeler of surgical kit devices, from July 14-18, 2025, revealed significant deficiencies in its quality management system. The inspection, performed under the Federal Food, Drug, and Cosmetic Act, identified five key observations indicating non-compliance with the Quality System Regulation. Specifically, Leesar Inc lacked established procedures for management review, showing no documentation that executive management routinely assesses the quality system's suitability and effectiveness. The firm also failed to create a comprehensive quality manual detailing its quality system structure and referencing essential procedures. A critical concern was the absence of established corrective and preventive action (CAPA) procedures, evidenced by uninvestigated complaints regarding foreign matter, including debris, insects, and human hair, found within sterile surgical kits. These complaints, indicating a potential failure to meet sterilization specifications, were not properly reviewed, evaluated, or investigated by the company. Lastly, the inspection noted a lack of documentation for the sterilization protocol and validation activities, providing no assurance that the sterile surgical kit process consistently achieves sterility. Leesar Inc has committed to correcting all identified observations. These findings necessitate prompt and thorough corrective actions to ensure compliance and product safety.