FDA Inspection
Owensboro Health Regional HospitalOwensboro Health Regional Hospital – FDA Inspection, Aug 14, 2014
Record Details
This FDA Inspection record concerns Owensboro Health Regional Hospital, with an inspection on August 14, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 14, 2014
- Product Type
- Biologics
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ID · 5a3ba053-dc00-442f-8b27-0a938d3d4213
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 893528
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.65(c)Testing of representative samples of reagent lots
- 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 Owensboro Health Regional Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 9, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 7, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 29, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Owensboro Health Regional Hospital
- FDA Inspection 1238482 - 2024-04-18
- FDA Inspection 1094124 - 2019-05-17
- FDA Inspection 1013950 - 2017-06-09
- FDA Inspection 926634 - 2015-05-07
- FDA Inspection 797502 - 2012-08-29
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