FDA Inspection
Cincinnati Childrens Hospital Medical CenterCincinnati Childrens Hospital Medical Center – FDA Inspection, Jul 12, 2023
Record Details
This FDA Inspection record concerns Cincinnati Childrens Hospital Medical Center, with an inspection on July 12, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 12, 2023
- Product Type
- Biologics
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ID · fb033dd0-3002-4162-ad2a-66c82ad9c087
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210327
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
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Other FDA inspections of Cincinnati Childrens Hospital Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2025 | Not classified | Cincinnati District Office | |
| August 19, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 14, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Cincinnati Childrens Hospital Medical Center
- FDA Inspection 1260751 - 2025-02-05
- FDA Inspection 1149625 - 2021-08-19
- FDA Inspection 1079825 - 2019-02-14
- FDA Inspection 1066736 - 2018-09-20
- FDA Inspection 992006 - 2016-11-15
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