Catholic Health Initiatives Institute
Form 483 issued March 3, 2026 · Englewood, Colorado
- Inspection
- Feb 23 – Mar 3, 2026
- Investigator
- Courtney R. Bratina
- Observations
- 1
- Pages
- 2
- FEI number
- 3013827563
In short: On March 3, 2026, FDA issued a Form 483 with 1 observation to Catholic Health Initiatives Institute in Englewood, Colorado (FEI 3013827563) after an inspection that ran Feb 23 – Mar 3, 2026. The investigator was Courtney R. Bratina. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 56.111 (criteria for IRB approval of research).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 56.111(a)(5) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The IRB approved the conduct of research, but did not determine that informed consent…
This inspection in context
Courtney R. Bratina
1 document · 2026
Cites 56.111(a)(5) (criteria for irb approval of research) more than any other section. Most of their documents are for sites in Colorado.
The firmCatholic Health Initiatives Institute history
The site's inspection history, in date order.
Similar 483sOther sites cited under 56.111(a)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catholic Health Initiatives Institute?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 56.111 (criteria for IRB approval of research). The opening words of each observation are shown on this page.
Who inspected Catholic Health Initiatives Institute?
Courtney R. Bratina is named on this Form 483, for the inspection of Feb 23 – Mar 3, 2026. Each investigator has a profile showing what they cite most.
When was Catholic Health Initiatives Institute inspected by FDA?
The inspection ran Feb 23 – Mar 3, 2026, and the Form 483 is dated March 3, 2026.
How do I get the full Form 483 for Catholic Health Initiatives Institute?
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.