FDA Inspection
Lions Medical Eye Bank & Research Center of Eastern VALions Medical Eye Bank & Research Center of Eastern VA – FDA Inspection, Feb 16, 2023
Record Details
This FDA Inspection record concerns Lions Medical Eye Bank & Research Center of Eastern VA, with an inspection on February 16, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 16, 2023
- Product Type
- Biologics
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ID · d8b448a7-f9f3-4927-9e63-63b4522ebe39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1197940
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.225Verification/validation
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.225Verification/validation
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Other FDA inspections of Lions Medical Eye Bank & Research Center of Eastern VA
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2025 | VAI | Baltimore District Office | Human Cellular, Tissue, and Gene Therapies |
| November 15, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 27, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 22, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 28, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Lions Medical Eye Bank & Research Center of Eastern VA
- FDA Inspection 1260767 - 2025-02-11
- FDA Inspection 1112314 - 2019-11-15
- FDA Inspection 1031841 - 2017-10-27
- FDA Inspection 960003 - 2016-01-22
- FDA Inspection 889183 - 2014-07-28
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