FDA Inspection
Baptist Health HardinBaptist Health Hardin – FDA Inspection, Mar 3, 2015
Record Details
This FDA Inspection record concerns Baptist Health Hardin, with an inspection on March 3, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Baptist Health Hardin
- Inspection Date
- March 3, 2015
- Product Type
- Biologics
View Company Profile
ID · 9926f81f-3428-4380-b216-97119c9538fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917307
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
9- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.140(b)Provisions to monitor lab test procedures & instruments
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.121(c)(1)Proper name of product
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 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 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 |
| January 15, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 13, 2012 | VAI | 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 814343 - 2013-01-15
- FDA Inspection 810741 - 2012-12-13
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