FDA Inspection
Baptist Health HardinBaptist Health Hardin – FDA Inspection, Dec 13, 2012
Record Details
This FDA Inspection record concerns Baptist Health Hardin, with an inspection on December 13, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Baptist Health Hardin
- Inspection Date
- December 13, 2012
- Product Type
- Biologics
View Company Profile
ID · 6414be7e-7084-40b2-b5d4-621c7cd9e0d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810741
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.170(b)Adverse reaction - fatality
- 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 Hardin
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 15, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Baptist Health Hardin
- FDA Inspection 1156222 - 2021-10-29
- FDA Inspection 1050606 - 2018-05-01
- FDA Inspection 956230 - 2016-01-13
- FDA Inspection 917307 - 2015-03-03
- FDA Inspection 814343 - 2013-01-15
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