FDA Inspection
Eye Bank For Sight Restoration Inc.FDA Inspection 846589 - Eye Bank For Sight Restoration Inc. - September 05, 2013
Record Details
This FDA Inspection record concerns Eye Bank For Sight Restoration Inc., with an inspection on September 5, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 5, 2013
- Product Type
- Biologics
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ID · cd8a7cd7-d65d-46b6-8580-2d39d2960c81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 846589
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.270(a)Accurate, indelible, legible
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Other FDA inspections of Eye Bank For Sight Restoration Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 |
| 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 1222700 - 2023-11-13
- FDA Inspection 1097897 - 2019-06-25
- FDA Inspection 989231 - 2016-10-07
- FDA Inspection 730501 - 2011-06-16
- FDA Inspection 554161 - 2008-12-30
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