FDA Inspection
San Diego Eye BankSan Diego Eye Bank – FDA Inspection, Jul 21, 2010
Record Details
This FDA Inspection record concerns San Diego Eye Bank, with an inspection on July 21, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- San Diego Eye Bank
- Inspection Date
- July 21, 2010
- Product Type
- Biologics
View Company Profile
ID · 4f815b4c-7de7-4e52-a288-c73a019f7684
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 672042
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.160(b)(5)Monitoring systems
Full citation text and observation details available on the Dashboard.
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 |
| 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 1237570 - 2024-05-03
- FDA Inspection 1032340 - 2017-11-03
- FDA Inspection 929480 - 2015-05-29
- FDA Inspection 799479 - 2012-08-30
- FDA Inspection 611083 - 2009-09-08
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