Denver Health Medical Center
Form 483 issued June 5, 2025 · Denver, Colorado
- Inspection
- Jun 2 – Jun 5, 2025
- Observations
- 2
- Pages
- 3
- FEI number
- 1000065349
In short: On June 5, 2025, FDA issued a Form 483 with 2 observations to Denver Health Medical Center in Denver, Colorado (FEI 1000065349) after an inspection that ran Jun 2 – Jun 5, 2025. Most observations concern facilities & equipment and biologics CGMP; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and biologics cgmp account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 21 CFR 606.151(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Input to and output from the computer are…
- 0221 CFR 606.151(e)
Records including signature by the physician requesting the procedure are not maintained…
This inspection in context
Questions about this 483
What did FDA find at Denver Health Medical Center?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and biologics CGMP. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Denver Health Medical Center inspected by FDA?
The inspection ran Jun 2 – Jun 5, 2025, and the Form 483 is dated June 5, 2025.
How do I get the full Form 483 for Denver Health Medical Center?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.