FDA Inspection
Lions Eye Bank of Wisconsin, Inc.Lions Eye Bank of Wisconsin, Inc. – FDA Inspection, Sep 16, 2016
Record Details
This FDA Inspection record concerns Lions Eye Bank of Wisconsin, Inc., with an inspection on September 16, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 16, 2016
- Product Type
- Biologics
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ID · e0b9fdc9-87e4-4c29-9529-4b3a20ec8c03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985369
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.160(d)Documentation/approval prior to implementation
- 21 CFR 1271.150(c)(2)Responsibility for review before distribution
- 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 Lions Eye Bank of Wisconsin, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2026 | Not classified | Minneapolis District Office | Human Cellular, Tissue, and Gene Therapies |
| January 12, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 21, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 11, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 1, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Lions Eye Bank of Wisconsin, Inc.
- FDA Inspection 1326084 - 2026-07-06
- FDA Inspection 1196932 - 2023-01-12
- FDA Inspection 1057950 - 2018-06-21
- FDA Inspection 858328 - 2013-12-11
- FDA Inspection 752435 - 2011-11-01
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