FDA Inspection
Warren General HospitalWarren General Hospital – FDA Inspection, Jul 7, 2016
Record Details
This FDA Inspection record concerns Warren General Hospital, with an inspection on July 7, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Warren General Hospital
- Inspection Date
- July 7, 2016
- Product Type
- Biologics
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ID · 75fe0550-d043-42e2-b8cd-5d8931f0d5d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 979169
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)(13)Procedures to relate blood from donor to final disposition
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Other FDA inspections of Warren General Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 10, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 28, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Warren General Hospital
- FDA Inspection 1031114 - 2017-10-19
- FDA Inspection 873916 - 2014-04-10
- FDA Inspection 772474 - 2012-03-13
- FDA Inspection 659428 - 2010-04-28
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