DCI Donor Services, Inc.
Form 483 issued August 28, 2025
- Inspection
- Aug 19 – Aug 28, 2025
- Investigators
- Christopher J. Adams· Fabian N. Chaparro-Rodriguez· Jannet M. Peroti
- Observations
- 3
- Pages
- 5
- FEI number
- 1000307504
In short: On August 28, 2025, FDA issued a Form 483 with 3 observations to DCI Donor Services, Inc. (FEI 1000307504) after an inspection that ran Aug 19 – Aug 28, 2025. The investigators were Christopher J. Adams, Fabian N. Chaparro-Rodriguez and Jannet M. Peroti. Most observations concern hCT/P.
At a glance
3 of 3 observations on this 483 concern hct/p.
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 determined to be ineligible that had risk factors or clinical evidence…
- 02
Facilities were not maintained in a…
- 03
Equipment used for manufacturing HCT/Ps was not cleaned…
This inspection in context
Christopher J. Adams
3 documents · 2023–2025
Cites 1271.190 (facilities) more than any other section. Most of their documents are for sites in North Carolina.
The firmDCI Donor Services, Inc. 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 DCI Donor Services, Inc.?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.
Who inspected DCI Donor Services, Inc.?
Christopher J. Adams, Fabian N. Chaparro-Rodriguez and Jannet M. Peroti are named on this Form 483, for the inspection of Aug 19 – Aug 28, 2025. Each investigator has a profile showing what they cite most.
When was DCI Donor Services, Inc. inspected by FDA?
The inspection ran Aug 19 – Aug 28, 2025, and the Form 483 is dated August 28, 2025.
How do I get the full Form 483 for DCI Donor Services, 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.