FDA 483 - Cerapedics, Inc. - October 24, 2019

Cerapedics, Inc. in Westminster, CO, was inspected by the FDA from October 22-24, 2019. The inspection revealed a significant deficiency in their medical device reporting (MDR) process. Specifically, the firm failed to submit an MDR report within 30 days for a serious injury involving their iFactor bone graft putty, despite internal recognition of its reportability.