Global Premier Fertility Orange County LLC
Form 483 issued April 11, 2025 · Newport Beach, California
- Inspection
- Apr 9 – Apr 11, 2025
- Investigator
- Melsomar R. Ramos
- Observations
- 3
- Pages
- 3
- FEI number
- 3018118424
In short: On April 11, 2025, FDA issued a Form 483 with 3 observations to Global Premier Fertility Orange County LLC in Newport Beach, California (FEI 3018118424) after an inspection that ran Apr 9 – Apr 11, 2025. The investigator was Melsomar R. Ramos. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?).
At a glance
3 of 3 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
The accompanying records for HCT/Ps included the donor's name and personal information that…
- 02
The summary of records for HCT/Ps did not contain a statement that the communicable disease testing…
- 03
Documentation of the donor-eligibility determination and the date of the donor-eligibility…
This inspection in context
Melsomar R. Ramos
2 documents · 2025–2026
Cites 1271.55(b)(1) (what records must accompany an hct/p after the donor-eligibility determination is complete; and what records must i retain?) more than any other section. Most of their documents are for sites in California.
The firmGlobal Premier Fertility Orange County LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.55(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Global Premier Fertility Orange County LLC?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?). The opening words of each observation are shown on this page.
Who inspected Global Premier Fertility Orange County LLC?
Melsomar R. Ramos is named on this Form 483, for the inspection of Apr 9 – Apr 11, 2025. Each investigator has a profile showing what they cite most.
When was Global Premier Fertility Orange County LLC inspected by FDA?
The inspection ran Apr 9 – Apr 11, 2025, and the Form 483 is dated April 11, 2025.
How do I get the full Form 483 for Global Premier Fertility Orange County 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.