FDA Inspection
Stratton VA Medical Center Transfusion Service (113c)Stratton VA Medical Center Transfusion Service (113c) – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns Stratton VA Medical Center Transfusion Service (113c), with an inspection on April 28, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 28, 2017
- Product Type
- Biologics
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ID · b82c1d99-c6d2-4703-95b7-08bbbee8d958
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013357
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.140(b)Provisions to monitor lab test procedures & instruments
- 21 CFR 606.100(b)SOPs for investigations, records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stratton VA Medical Center Transfusion Service (113c)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 9, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 18, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 25, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stratton VA Medical Center Transfusion Service (113c)
- FDA Inspection 1237475 - 2024-04-22
- FDA Inspection 1097504 - 2019-07-09
- FDA Inspection 926893 - 2015-05-20
- FDA Inspection 827701 - 2013-04-18
- FDA Inspection 726821 - 2011-05-25
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