FDA Inspection
Baptist Health Deaconess Madisonville IncBaptist Health Deaconess Madisonville Inc – FDA Inspection, Jan 31, 2014
Record Details
This FDA Inspection record concerns Baptist Health Deaconess Madisonville Inc, with an inspection on January 31, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 31, 2014
- Product Type
- Biologics
View Company Profile
ID · c021811c-2a37-435f-94ba-01c46851c27d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865925
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 640.31Donor eligibility
- 21 CFR 610.47(a)Lookback System [Collecting Establishment]
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
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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