FDA Inspection
Asante Rogue Regional Medical CenterAsante Rogue Regional Medical Center – FDA Inspection, Feb 7, 2013
Record Details
This FDA Inspection record concerns Asante Rogue Regional Medical Center, with an inspection on February 7, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 7, 2013
- Product Type
- Biologics
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ID · f64c935b-511d-4c7d-bf8b-183e3cb32bbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 818344
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Asante Rogue Regional Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 27, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 3, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 31, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Asante Rogue Regional Medical Center
- FDA Inspection 1238696 - 2024-05-08
- FDA Inspection 1087623 - 2019-03-28
- FDA Inspection 1019446 - 2017-07-27
- FDA Inspection 913613 - 2015-02-03
- FDA Inspection 854469 - 2013-10-31
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