FDA 483 - Pedicraft, Inc. - July 25, 2025

Pedicraft, Inc. in Jacksonville, FL, was inspected by the FDA from July 22-25, 2025, revealing two significant repeat observations. The firm failed to adequately establish procedures for corrective and preventive action, neglecting to open CAPAs for previous inspection findings. Additionally, individuals conducting quality audits had direct responsibility for the matters being audited, contrary to their own updated procedures.