FDA Inspection
Baptist Health Deaconess Madisonville IncBaptist Health Deaconess Madisonville Inc – FDA Inspection, Apr 24, 2025
Record Details
This FDA Inspection record concerns Baptist Health Deaconess Madisonville Inc, with an inspection on April 24, 2025, issued by the Cincinnati District Office, covering biologics.
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ID · 7b563871-8eed-4e0e-bfe2-fc8c18ed23d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267808
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Baptist Health Deaconess Madisonville Inc
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 14, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 13, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Baptist Health Deaconess Madisonville Inc
- FDA Inspection 1197480 - 2023-01-18
- FDA Inspection 1092853 - 2019-05-14
- FDA Inspection 1003399 - 2017-03-03
- FDA Inspection 916394 - 2015-02-13
- FDA Inspection 865925 - 2014-01-31
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