FDA Inspection
Eye Bank For Sight Restoration Inc.FDA Inspection 730501 - Eye Bank For Sight Restoration Inc. - June 16, 2011
Record Details
This FDA Inspection record concerns Eye Bank For Sight Restoration Inc., with an inspection on June 16, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 16, 2011
- Product Type
- Biologics
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ID · a11f8ed6-1d62-4a96-a1f5-50ead78ea8a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730501
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.80(c)Manufacturer instructions not followed
Full citation text and observation details available on the Dashboard.
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 |
| September 5, 2013 | 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 846589 - 2013-09-05
- FDA Inspection 554161 - 2008-12-30
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