FDA 483 - Implant Direct Sybron Manufacturing LLC - May 12, 2021

Implant Direct Sybron Manufacturing LLC in Thousand Oaks, CA, a medical device manufacturer, was cited for inadequate documentation of corrective and preventive action activities. The firm failed to properly document corrective actions for multiple in-process non-conformances related to labeling and packaging issues, including part mix-ups and missing components. This indicates a significant lapse in their quality system regarding CAPA implementation and record-keeping.