Americord Registry LLC
Form 483 issued November 17, 2025 · Somerset, New Jersey
- Inspection
- Nov 4 – Nov 17, 2025
- Investigator
- Irina Gaberman
- Observations
- 17
- Pages
- 9
- FEI number
- 3006988080
In short: On November 17, 2025, FDA issued a Form 483 with 17 observations to Americord Registry LLC in Somerset, New Jersey (FEI 3006988080) after an inspection that ran Nov 4 – Nov 17, 2025. The investigator was Irina Gaberman. Most observations concern hCT/P and production; the most-cited regulation is 21 CFR 1271.60 (what quarantine and other requirements apply before the donor-eligibility determination is complete?).
At a glance
14 of 17 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.60 (3×) · 1271.270 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Processes with results which could not be fully verified by inspection and tests, were not validated…
- 02
EMPLOYEE(S> SIGNATURE You did not establish and maintain procedures for testing, screening and determining the…
- 03
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based…
- 04
HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not accompanied by…
This inspection in context
Irina Gaberman
8 documents · 2011–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmAmericord Registry LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Americord Registry LLC?
FDA listed 17 observations on this Form 483, mostly about hCT/P, production and laboratory controls. The most-cited regulation is 21 CFR 1271.60 (what quarantine and other requirements apply before the donor-eligibility determination is complete?). The opening words of each observation are shown on this page.
Who inspected Americord Registry LLC?
Irina Gaberman is named on this Form 483, for the inspection of Nov 4 – Nov 17, 2025. Each investigator has a profile showing what they cite most.
When was Americord Registry LLC inspected by FDA?
The inspection ran Nov 4 – Nov 17, 2025, and the Form 483 is dated November 17, 2025.
How do I get the full Form 483 for Americord Registry LLC?
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.