FDA 483 - Miach Orthopaedics - April 23, 2025

An FDA inspection of Miach Orthopaedics in Westborough, MA, a manufacturer of the BEAR Implant medical device, revealed significant deficiencies across its quality system. Observations included inadequate procedures for process control, design verification and validation related to implant hydration, and a failure to adequately manage complaints and corrective actions. These issues raise concerns about the device's quality, safety, and consistent performance in the field.