Billings Clinic Fertility Specialists
Form 483 issued February 26, 2025
- Inspection
- Feb 25 – Feb 26, 2025
- Investigator
- Emily S. McGann
- Observations
- 3
- Pages
- 4
- FEI number
- 3028586894
In short: On February 26, 2025, FDA issued a Form 483 with 3 observations to Billings Clinic Fertility Specialists (FEI 3028586894) after an inspection that ran Feb 25 – Feb 26, 2025. The investigator was Emily S. McGann. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.50 (how do I determine whether a donor is eligible?).
At a glance
3 of 3 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.50 (2×) · 1271.85 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
HCT/P donors were not determined to be eligible based on the results of…
- 02
Donors were not tested for evidence of infection with…
- 03
The eligibility of an HCT/P donor was not by a responsible person, based on results of…
This inspection in context
Emily S. McGann
6 documents · 2024–2026
Cites 1271.50 (how do i determine whether a donor is eligible?) more than any other section. Most of their documents are for sites in Arizona.
The firmBillings Clinic Fertility Specialists history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Billings Clinic Fertility Specialists?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.50 (how do I determine whether a donor is eligible?). The opening words of each observation are shown on this page.
Who inspected Billings Clinic Fertility Specialists?
Emily S. McGann is named on this Form 483, for the inspection of Feb 25 – Feb 26, 2025. Each investigator has a profile showing what they cite most.
When was Billings Clinic Fertility Specialists inspected by FDA?
The inspection ran Feb 25 – Feb 26, 2025, and the Form 483 is dated February 26, 2025.
How do I get the full Form 483 for Billings Clinic Fertility Specialists?
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.