Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-05.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2025 – 5 Jun 2025 | Biologics | 483 | View 483 → |
| 4 Mar 2020 – 6 Mar 2020 | Biologics | Clean | |
| 23 Oct 2017 – 26 Oct 2017 | Biologics | Clean | |
| 19 Nov 2015 – 23 Nov 2015 | Biologics | Clean | |
| 10 Dec 2013 – 12 Dec 2013 | Biologics | 483 | On file |
| 23 May 2012 | Not recorded | Clean | |
| 30 Jun 2010 | Not recorded | 483 | View 483 → |
| 11 Apr 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jun 2025
21 CFR 606.151(e)
Procedures to maintain records of emergency transfusions
Cited by Emily B Camire
Investigators
FDA investigators tied to this site in the record.
Kelly D Moore2 insp.
Emily B Camire1 insp.
Paul M Chefor1 insp.
Marc A Jackson1 insp.
Daniel P Stlaurent1 insp.
Carla R Hinz1 insp.
Theressa B Smith1 insp.
Hanna L Potter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.151(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Denver Health Medical Center's 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat