FDA WARNING_LETTER - Exactech, Inc. - July 25, 2025

The FDA issued a Warning Letter to Exactech, Inc. dba Advita Ortho following an inspection from July 15-25, 2025, at its Sarasota, Florida facility. The inspection revealed that the company"s medical devices, including the Equinoxe Reverse Shoulder Compression Screw, were manufactured under conditions not conforming to the Quality System Regulation (21 CFR Part 820) of the Federal Food, Drug, and Cosmetic Act. Key violations included a failure to establish and maintain adequate process control procedures, such as defining material specifications for UHMWPE powder and ensuring consistent in-process inspection for critical device dimensions. The company also failed to implement effective corrective and preventative actions, with manufacturing deviations and environmental monitoring excursions not consistently analyzed or escalated. Deficiencies were noted in controlling nonconforming products, lacking clear procedures for handling manufacturing events and scrap, which the FDA believes poses a potential risk to distributed products. Additionally, Exactech failed to maintain adequate environmental controls for raw material storage, properly manage purchased products by not auditing a critical supplier or maintaining quality agreements, and ensure comprehensive training documentation for employees on required inspection tools. Lastly, the company lacked established procedures for acceptance activities, including incorrect work instructions and missing procedures for critical quality control inspection tools. Exactech"s responses to these observations were largely deemed inadequate, with many corrective actions still in progress. The FDA requires the company to take prompt action, detailing specific steps, preventive measures, and a comprehensive timeline within fifteen business days to avoid further regulatory enforcement actions.