Conceive Fertility Center
Form 483 issued June 13, 2025 · Dallas, Texas
- Inspection
- Jun 6 – Jun 13, 2025
- Investigator
- Ramon L. Gonzalez-Prieto
- Observations
- 5
- Pages
- 4
- FEI number
- 3014721365
In short: On June 13, 2025, FDA issued a Form 483 with 5 observations to Conceive Fertility Center in Dallas, Texas (FEI 3014721365) after an inspection that ran Jun 6 – Jun 13, 2025. The investigator was Ramon L. Gonzalez-Prieto. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.47 (what procedures must I establish and maintain?).
At a glance
5 of 5 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.55 (2×) · 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
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a statement whether the…
- 02
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based…
- 03
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus…
- 04
You did not establish and maintain procedures for testing, screening and determining the…
This inspection in context
Ramon L. Gonzalez-Prieto
2 documents · 2025
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in Texas.
The firmConceive Fertility Center history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.55
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Conceive Fertility Center?
FDA listed 5 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 Conceive Fertility Center?
Ramon L. Gonzalez-Prieto is named on this Form 483, for the inspection of Jun 6 – Jun 13, 2025. Each investigator has a profile showing what they cite most.
When was Conceive Fertility Center inspected by FDA?
The inspection ran Jun 6 – Jun 13, 2025, and the Form 483 is dated June 13, 2025.
How do I get the full Form 483 for Conceive 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.