FDA Inspection
VA Black Hills Health Care SystemVA Black Hills Health Care System – FDA Inspection, Aug 26, 2025
Record Details
This FDA Inspection record concerns VA Black Hills Health Care System, with an inspection on August 26, 2025, issued by the Minneapolis District Office, covering biologics.
- Person
View Company Profile
ID · 0dd35410-e299-4bd8-91ff-4610161a1d37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1279582
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.160(a)(1)Concurrent documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VA Black Hills Health Care System
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 19, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 22, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 28, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 7, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VA Black Hills Health Care System
- FDA Inspection 1095226 - 2019-06-20
- FDA Inspection 1022941 - 2017-07-19
- FDA Inspection 940747 - 2015-07-22
- FDA Inspection 822706 - 2013-02-28
- FDA Inspection 734441 - 2011-07-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.