FDA 483 - Vericel Corporation - September 25, 2024

Vericel Corporation in Cambridge, MA, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within the required 30 days for malfunctions that could cause serious injury or death. Additionally, their corrective and preventive action (CAPA) procedures were found to be inadequate, specifically lacking requirements for verifying or validating the effectiveness of all CAPAs.