FDA Inspection
George E Wahlen VA Medical Center Transfusion Service MC113George E Wahlen VA Medical Center Transfusion Service MC113 – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns George E Wahlen VA Medical Center Transfusion Service MC113, with an inspection on May 23, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 23, 2018
- Product Type
- Biologics
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ID · 3f4f1101-fd3a-4e24-9317-2ff8c383b010
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053957
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of George E Wahlen VA Medical Center Transfusion Service MC113
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2026 | Not classified | Denver District Office | |
| April 27, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 2, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 28, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 7, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for George E Wahlen VA Medical Center Transfusion Service MC113
- FDA Inspection 1298260 - 2026-01-09
- FDA Inspection 1168936 - 2022-04-27
- FDA Inspection 966889 - 2015-12-02
- FDA Inspection 871852 - 2014-03-28
- FDA Inspection 756146 - 2011-12-07
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