FDA Inspection
Baptist Health Deaconess Madisonville IncBaptist Health Deaconess Madisonville Inc – FDA Inspection, Feb 2, 2011
Record Details
This FDA Inspection record concerns Baptist Health Deaconess Madisonville Inc, with an inspection on February 2, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 2, 2011
- Product Type
- Biologics
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ID · 19538f28-6b9b-4ea2-91f0-ddab312a6eb4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 708986
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 640.31Donor eligibility
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.4(f)Arm preparation
- 21 CFR 211.100(b)SOPs not followed / documented
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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