FDA Inspection
Baptist Health FloydBaptist Health Floyd – FDA Inspection, Nov 30, 2010
Record Details
This FDA Inspection record concerns Baptist Health Floyd, with an inspection on November 30, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Baptist Health Floyd
- Inspection Date
- November 30, 2010
- Product Type
- Biologics
View Company Profile
ID · 4853ae96-f3d0-4508-8c79-4d4cb41f64ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 700530
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Baptist Health Floyd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 25, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 31, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Baptist Health Floyd
- FDA Inspection 1249342 - 2024-09-05
- FDA Inspection 1067693 - 2018-09-13
- FDA Inspection 980887 - 2016-07-22
- FDA Inspection 905338 - 2014-11-25
- FDA Inspection 806416 - 2012-10-31
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