Columbia University Fertility Center
Form 483 issued December 20, 2024
- Inspection
- Dec 12 – Dec 20, 2024
- Observations
- 5
- Pages
- 4
- FEI number
- 3003972435
In short: On December 20, 2024, FDA issued a Form 483 with 5 observations to Columbia University Fertility Center (FEI 3003972435) after an inspection that ran Dec 12 – Dec 20, 2024. 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
5 of 5 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.50(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Donor specimens used for testing of communicable disease agents were not collected…
- 02
HCT/P donors were not determined to be eligible based on the results of…
- 03
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based…
- 04
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with…
This inspection in context
Questions about this 483
What did FDA find at Columbia University Fertility Center?
FDA listed 5 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.
When was Columbia University Fertility Center inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2024, and the Form 483 is dated December 20, 2024.
How do I get the full Form 483 for Columbia University Fertility Center?
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.