FDA Inspection
San Diego Eye BankSan Diego Eye Bank – FDA Inspection, Sep 8, 2009
Record Details
This FDA Inspection record concerns San Diego Eye Bank, with an inspection on September 8, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- San Diego Eye Bank
- Inspection Date
- September 8, 2009
- Product Type
- Biologics
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ID · ce58b485-be46-467a-be12-80ffd312f256
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611083
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
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Other FDA inspections of San Diego Eye Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
Other documents for San Diego Eye Bank
- FDA Inspection 1237570 - 2024-05-03
- FDA Inspection 1032340 - 2017-11-03
- FDA Inspection 929480 - 2015-05-29
- FDA Inspection 799479 - 2012-08-30
- FDA Inspection 672042 - 2010-07-21
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