FDA Inspection
CorneaGen, LLCCorneaGen, LLC – FDA Inspection, May 31, 2023
Record Details
This FDA Inspection record concerns CorneaGen, LLC, with an inspection on May 31, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a5146096-70a5-4e18-b1d1-ad5e2643b3e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207713
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.210(d)(2)Verification elements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CorneaGen, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 14, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 20, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 22, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 28, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CorneaGen, LLC
- FDA Inspection 1337312 - 2026-09-16
- FDA Inspection 1149011 - 2021-07-14
- FDA Inspection 1061992 - 2018-07-20
- FDA Inspection 946041 - 2015-10-22
- FDA Inspection 870037 - 2014-02-28
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