FDA Inspection
Eye Bank For Sight Restoration Inc.FDA Inspection 1222700 - Eye Bank For Sight Restoration Inc. - November 13, 2023
Record Details
This FDA Inspection record concerns Eye Bank For Sight Restoration Inc., with an inspection on November 13, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 34681037-473e-4d88-ad6f-4e187867a3da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222700
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.210(a)Use prior to verification
- 21 CFR 1271.270(a)Accurate, indelible, legible
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.270(a)Records maintained concurrently
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Other FDA inspections of Eye Bank For Sight Restoration Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 5, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 16, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 30, 2008 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Eye Bank For Sight Restoration Inc.
- FDA Inspection 1097897 - 2019-06-25
- FDA Inspection 989231 - 2016-10-07
- FDA Inspection 846589 - 2013-09-05
- FDA Inspection 730501 - 2011-06-16
- FDA Inspection 554161 - 2008-12-30
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