FDA Inspection
San Diego Eye BankSan Diego Eye Bank – FDA Inspection, May 3, 2024
Record Details
This FDA Inspection record concerns San Diego Eye Bank, with an inspection on May 3, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f5c986c3-02f4-4ae3-b165-6cffbe2c5a81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237570
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of San Diego Eye Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 29, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 30, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 21, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 8, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for San Diego Eye Bank
- FDA Inspection 1032340 - 2017-11-03
- FDA Inspection 929480 - 2015-05-29
- FDA Inspection 799479 - 2012-08-30
- FDA Inspection 672042 - 2010-07-21
- FDA Inspection 611083 - 2009-09-08
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