FDA Inspection
CorneaGen - BostonCorneaGen - Boston – FDA Inspection, Dec 20, 2024
Record Details
This FDA Inspection record concerns CorneaGen - Boston, with an inspection on December 20, 2024, issued by the New England District Office, covering biologics.
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ID · 43ca6f6d-9fc0-4574-8a2c-ae5be00b98c8
Inspection Facts
- Inspection number
- 1257221
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.265(c)(2)Improperly released for distribution
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of CorneaGen - Boston
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2023 | Not classified | New England District Office | |
| March 5, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| September 12, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 20, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 28, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CorneaGen - Boston
- FDA Inspection 1207719 - 2023-06-09
- FDA Inspection 1121216 - 2020-03-05
- FDA Inspection 1068364 - 2018-09-12
- FDA Inspection 941531 - 2015-08-20
- FDA Inspection 824487 - 2013-03-28
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