# FDA 483 - Vericel Corporation - September 25, 2024

Source: https://www.keypedia.com/records/483/vericel-corporation/7ef5bcce-bff7-43be-a086-a663c995e318

> FDA 483 for Vericel Corporation on September 25, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vericel Corporation
- Inspection Date: 2024-09-25
- Product Type: biologics
- Office Name: New England District Office
- Summary: 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.

## Related Documents

- [483 - 2023-07-21](https://www.keypedia.com/records/483/vericel-corporation/e1d22958-7161-4349-b22f-265b47f366d9)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/vericel-corporation/1955c523-5115-491b-a705-2c526deb9ff6

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144