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Exactech, Inc., a manufacturer of orthopedic implants including Equinoxe aTSA and Equinoxe rTSA devices, was cited for failing to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The inspection conducted September 18-26, 2023 identified critical deficiencies in the company's corrective and preventive actions (CAPA) procedures, specifically finding that their CAPA and Quality Data Analysis Review processes failed to adequately establish standardized procedures for analyzing quality data to identify, correct, and prevent recurrence of nonconforming product. The devices were deemed adulterated due to inadequate manufacturing controls, facilities, and quality system documentation.