FDA Inspection
CorneaGen - Orlando / Medical Eye Bank of FloridaCorneaGen - Orlando / Medical Eye Bank of Florida – FDA Inspection, Apr 1, 2015
Record Details
This FDA Inspection record concerns CorneaGen - Orlando / Medical Eye Bank of Florida, with an inspection on April 1, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 1, 2015
- Product Type
- Biologics
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ID · dc2f59e6-4fb0-4a40-9bd7-38bfc513f2f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920736
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.350(a)(2)15 day reporting timeframe
- 21 CFR 1271.180(b)Review and approval-responsible person
- 21 CFR 1271.230(a)Documented, dated, signed
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Other FDA inspections of CorneaGen - Orlando / Medical Eye Bank of Florida
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | Not classified | Florida District Office | |
| January 11, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 12, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 10, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 14, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CorneaGen - Orlando / Medical Eye Bank of Florida
- FDA Inspection 1259432 - 2025-01-16
- FDA Inspection 1195656 - 2023-01-11
- FDA Inspection 1117920 - 2019-12-12
- FDA Inspection 1028794 - 2017-08-10
- FDA Inspection 818771 - 2013-02-14
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