# CorneaGen, LLC – FDA Inspection, May 31, 2023

Source: https://www.keypedia.com/records/fda_inspections/corneagen-llc/a5146096-70a5-4e18-b1d1-ad5e2643b3e7
Source feed: FDA_Inspections

> FDA inspection 1207713 of CorneaGen, LLC, May 31, 2023. Classification: Voluntary Action Indicated (VAI). 2 citations under 21 CFR part 1271. Form 483 issued. 7 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1207713
- Company Name: CorneaGen, LLC
- Inspection Date: 2023-05-31
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Human Cellular, Tissue, and Gene Therapies
- Product Type: Biologics
- Center: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Citation Count: 2

## Related Documents

- FDA Inspection 1337312 - 2026-09-16
- FDA Inspection 1149011 - 2021-07-14
- [FDA Inspection 1061992 - 2018-07-20](https://www.keypedia.com/records/fda_inspections/corneagen-llc/6319f14a-8037-434b-b4c1-17288fdbe7f9)
- FDA Inspection 946041 - 2015-10-22
- FDA Inspection 870037 - 2014-02-28

## Related Officers

- [Company Rep](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)

Company: https://www.keypedia.com/companies/corneagen-llc/63b0f20d-2789-4c29-90c7-251cd951234a

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d