FDA 483 - Vericel Corporation - September 25, 2024

During an FDA inspection conducted from September 18-25, 2024, Vericel Corporation, a medical device manufacturer based in Cambridge, MA, received a Form FDA-483 citing two significant observations. The first observation detailed the company's failure to submit Medical Device Reports (MDRs) within the mandated 30-day timeframe. Specifically, seven out of nine reviewed MDRs for their Epicel cultured epidermal autograft (CEA) device, concerning malfunctions with the potential to cause death or serious injury, were reported late. For example, one report aware on March 25, 2024, was not submitted until June 18, 2024.

The second observation identified inadequacies in the firm's corrective and preventive action (CAPA) procedures. The company's CAPA process did not consistently require verification or validation of all corrective and preventive actions to ensure their effectiveness and prevent adverse effects on finished devices. Three out of twelve reviewed CAPAs, involving procedures for tracking systems, gauge revisions, and sanitation modifications, lacked the necessary effectiveness reviews.

These observations indicate non-compliance with regulatory requirements governing medical device reporting and quality system management. Vericel Corporation is expected to propose and implement comprehensive corrective actions in response to these findings to address the identified deficiencies and ensure full adherence to federal regulations.