# FDA 483 - Vericel Corporation - July 21, 2023

Source: https://www.keypedia.com/records/483/vericel-corporation/e1d22958-7161-4349-b22f-265b47f366d9

> FDA 483 for Vericel Corporation on July 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vericel Corporation
- Inspection Date: 2023-07-21
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: Vericel Corporation in Cambridge, MA, a manufacturer of cell therapy and medical devices, was inspected by the FDA from July 13-21, 2023. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control, and design verification for their MACI product. These issues indicate potential risks to product sterility and quality assurance.

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## Related Officers

- [Nancy G Berger](https://www.keypedia.com/people/nancy-g-berger/004896a3-d50d-45f1-bb46-36f9bbe4bdb5)
- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94