Exactech, Inc. – FDA Warning Letter, Sep 26, 2023

The FDA issued a Warning Letter to Mr. Johnson, President and CEO of a firm manufacturing Equinoxe aTSA and Equinoxe rTSA devices and other orthopedic implants, following an inspection from September 18-26, 2023. The inspection revealed that the firm's devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820). The firm's response dated October 13, 2023, to the FDA 483 observations was deemed inadequate.

Key violations include: 1. **Failure to adequately establish CAPA procedures (21 CFR 820.100(a)):** The firm's CAPA and Quality Data Analysis Review (QDAR) procedures lack standardized processes for analyzing quality data, leading to inconsistent failure mode coding in complaint trending (e.g., CASE-2023-00009390, CASE-2023-00009729). Additionally, the firm failed to identify actions for polyethylene shoulder implants with non-conforming packaging, and its Health Hazard Evaluation (HHE) did not adequately evaluate all applicable complaint data. 2. **Failure to establish and maintain design validation procedures for risk analysis (2