FDA Inspection
Denver Health Medical CenterDenver Health Medical Center – FDA Inspection, Jun 5, 2025
Record Details
This FDA Inspection record concerns Denver Health Medical Center, with an inspection on June 5, 2025, issued by the Denver District Office, covering biologics.
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ID · a476417d-1c09-406f-b5bb-fb918deea576
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271748
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 211.68(b)input/output verification
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Denver Health Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 23, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 12, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 23, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Denver Health Medical Center
- FDA Inspection 1122590 - 2020-03-06
- FDA Inspection 1031969 - 2017-10-26
- FDA Inspection 952023 - 2015-11-23
- FDA Inspection 858458 - 2013-12-12
- FDA Inspection 782953 - 2012-05-23
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