FDA Inspection
Lions Eye Bank of Wisconsin, Inc.Lions Eye Bank of Wisconsin, Inc. – FDA Inspection, Sep 16, 2010
Record Details
This FDA Inspection record concerns Lions Eye Bank of Wisconsin, Inc., with an inspection on September 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 16, 2010
- Product Type
- Biologics
View Company Profile
ID · 5ab9e53b-9b54-41fa-b946-bab953bd0f77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680209
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.210(a)Use prior to verification
- 21 CFR 1271.160(b)(3)Actions taken and documented
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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 |
| September 16, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 11, 2013 | NAI | 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 985369 - 2016-09-16
- FDA Inspection 858328 - 2013-12-11
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