# FDA 483 - Vericel Corporation - June 12, 2026

Source: https://www.keypedia.com/records/483/vericel-corporation/a6cf0044-e8d4-43f4-9a80-0b7df538c8c3

> FDA 483 for Vericel Corporation on June 12, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vericel Corporation
- Inspection Date: 2026-06-12
- Product Type: biologics
- Office Name: New England District Office
- Summary: Vericel Corporation in Cambridge, MA, received a Form 483 with four observations highlighting significant deficiencies in their manufacturing and quality control processes. The inspection revealed inadequate investigations into product leakage and the use of expired materials, insufficient controls over computer systems for data integrity, and failures in maintaining accurate batch records. These issues collectively indicate a need for improved quality management to ensure product quality and sterility.

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## Related Officers

- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)

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