FDA Warning Letter Highlights Quality Gaps at Advita Ortho Facility

The U.S. Food and Drug Administration has issued a warning letter to Advita Ortho following an inspection of a Florida manufacturing site linked to its Equinoxe Reverse Shoulder System.

The company, formed after acquiring assets from Exactech during bankruptcy, was cited for multiple quality and compliance deficiencies. These included failure to establish adequate product specifications, insufficient supplier oversight, and lack of defined manufacturing and inspection procedures.

Regulators also identified gaps in documentation related to production deviations and nonconformances, raising concerns about traceability and quality management. Additionally, the facility showed ongoing issues with environmental controls, including temperature and humidity excursions that could impact material integrity.

The warning follows prior recalls and compliance issues associated with Exactech, underscoring continued regulatory scrutiny and the need for strengthened quality systems.

15-03-2026