# FDA 483 - Vericel Corporation - Unknown Date

Source: https://www.keypedia.com/records/483/vericel-corporation/e23ab23c-6b82-431f-876d-b8deb9b9509b

> FDA 483 for Vericel Corporation on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vericel Corporation
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Vericel Corporation in Burlington, MA, was inspected from February 2-6, 2026, and received a Form 483. The inspection revealed significant deficiencies in aseptic processing practices and procedures for MACI drug product manufacturing. Operators were observed compromising aseptic conditions by exiting and re-entering biological safety cabinets without proper garment changes, and the firm's SOPs lacked critical detail regarding personnel hygiene and cleanroom practices.

## Related Officers

- [Jared D. Greenleaf](https://www.keypedia.com/people/jared-d-greenleaf/189acc23-624a-4f30-b1ca-bf92aef1de0a)
- [Zainab Y. Mansaray-Storms](https://www.keypedia.com/people/zainab-y-mansaray-storms/aa2981a8-20a3-4116-adc2-58d59024923f)
- [Wen (Aaron) Seeto](https://www.keypedia.com/people/wen-aaron-seeto/cddf7540-5d92-44a2-9ece-bc776e951b06)
- [Jessica Araujo](https://www.keypedia.com/people/jessica-araujo/50104345-28be-4c57-b77f-2d647f27c11c)

Company: https://www.keypedia.com/companies/vericel-corporation/5ad02c4b-4736-47d1-b55a-44beb892c7c0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4