Donor Alliance, Inc.
Form 483 issued January 15, 2026 · Denver, Colorado
- Inspection
- Jan 6 – Jan 15, 2026
- Investigators
- Conor J. McCarron· Deepa E. Vadakkan· Eric Zhu
- Observations
- 7
- Pages
- 7
- FEI number
- 3000215347
In short: On January 15, 2026, FDA issued a Form 483 with 7 observations to Donor Alliance, Inc. in Denver, Colorado (FEI 3000215347) after an inspection that ran Jan 6 – Jan 15, 2026. The investigators were Conor J. McCarron, Deepa E. Vadakkan, Eric Zhu and Shelley H. Beausoleil. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.47 (what procedures must I establish and maintain?).
At a glance
7 of 7 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.47 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Donors were not screened by a review of relevant medical records for of communicable…
- 02
Adverse reactions involving a conununicable disease related to…
- 03
Procedures were not designed to ensure compliance with the donor eligibility requirements. Your firm's written procedures…
- 04
Current donor eligibility procedures adopted from another organization were not verified to be consistent with the…
This inspection in context
Conor J. McCarron
3 documents · 2025–2026
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in Colorado.
The firmDonor Alliance, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.47
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Donor Alliance, Inc.?
FDA listed 7 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.47 (what procedures must I establish and maintain?). The opening words of each observation are shown on this page.
Who inspected Donor Alliance, Inc.?
Conor J. McCarron, Deepa E. Vadakkan, Eric Zhu and Shelley H. Beausoleil are named on this Form 483, for the inspection of Jan 6 – Jan 15, 2026. Each investigator has a profile showing what they cite most.
When was Donor Alliance, Inc. inspected by FDA?
The inspection ran Jan 6 – Jan 15, 2026, and the Form 483 is dated January 15, 2026.
How do I get the full Form 483 for Donor Alliance, Inc.?
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.