FDA Inspection
Vericel CorporationVericel Corporation – FDA Inspection, Jun 12, 2026
Record Details
This FDA Inspection record concerns Vericel Corporation, with an inspection on June 12, 2026, issued by the New England District Office, covering biologics.
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ID · 02e881c9-9b82-410c-b598-43e33c6e9d99
Inspection Facts
- Inspection number
- 1322008
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Vericel Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2024 | VAI | New England District Office | Compliance: Medical Devices |
| July 21, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 19, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 27, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Vericel Corporation
- FDA Inspection 1249999 - 2024-09-25
- FDA Inspection 1210597 - 2023-07-21
- FDA Inspection 1006746 - 2016-05-27
- FDA Inspection 870615 - 2014-03-19
- FDA Inspection 747422 - 2011-09-27
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