FDA Inspection
Baptist Health Deaconess Madisonville IncBaptist Health Deaconess Madisonville Inc – FDA Inspection, Dec 18, 2008
Record Details
This FDA Inspection record concerns Baptist Health Deaconess Madisonville Inc, with an inspection on December 18, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 18, 2008
- Product Type
- Biologics
View Company Profile
ID · af8b16dd-0231-4208-a34f-e9ad7d973c4c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 556025
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 606.100(a)SOP compliance
- 21 CFR 606.160(b)Required records
- 21 CFR 640.25(b)(4)Corrective action
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 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 |
|---|---|---|---|
| April 24, 2025 | VAI | Cincinnati District Office | Blood and Blood Products |
| 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 |
Other documents for Baptist Health Deaconess Madisonville Inc
- FDA Inspection 1267808 - 2025-04-24
- FDA Inspection 1197480 - 2023-01-18
- FDA Inspection 1092853 - 2019-05-14
- FDA Inspection 1003399 - 2017-03-03
- FDA Inspection 916394 - 2015-02-13
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