FDA Inspection
Vericel CorporationVericel Corporation – FDA Inspection, Aug 21, 2009
Record Details
This FDA Inspection record concerns Vericel Corporation, with an inspection on August 21, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Vericel Corporation
- Inspection Date
- August 21, 2009
- Product Type
- Biologics
View Company Profile
ID · 0c3973b6-e56f-4070-b7f7-a4b5a1a4dd38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 608350
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert
- 21 CFR 600.14(c)When to report
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vericel Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2026 | Not classified | New England District Office | Blood and Blood Products |
| 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 |
Other documents for Vericel Corporation
- FDA Inspection 1322008 - 2026-06-12
- FDA Inspection 1249999 - 2024-09-25
- FDA Inspection 1210597 - 2023-07-21
- FDA Inspection 1006746 - 2016-05-27
- FDA Inspection 870615 - 2014-03-19
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