FDA Inspection
Asante Rogue Regional Medical CenterAsante Rogue Regional Medical Center – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns Asante Rogue Regional Medical Center, with an inspection on July 27, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 50d7c35d-11f5-4d47-a507-c5427ec09952
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019446
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.65(e)Following manufacturer's instructions
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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 |
| 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 |
| February 7, 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 913613 - 2015-02-03
- FDA Inspection 854469 - 2013-10-31
- FDA Inspection 818344 - 2013-02-07
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