FDA 483 - Cerapedics, Inc. - March 13, 2024

Cerapedics, Inc., a medical device manufacturer in Westminster, CO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to timely report numerous serious adverse events for its i-FACTOR Putty, indicating systemic issues with its Medical Device Reporting, complaint handling, corrective and preventive action, and personnel training procedures. This includes a repeat observation regarding MDR reporting failures.