Elite IVF & Fertility Solutions LLC
Form 483 issued March 28, 2025 · Odessa, Texas
- Inspection
- Mar 27 – Mar 28, 2025
- Investigator
- Michelle Paxon
- Observations
- 2
- Pages
- 3
- FEI number
- 3023212478
In short: On March 28, 2025, FDA issued a Form 483 with 2 observations to Elite IVF & Fertility Solutions LLC in Odessa, Texas (FEI 3023212478) after an inspection that ran Mar 27 – Mar 28, 2025. The investigator was Michelle Paxon. 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
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.55(b)(3) (1×) · 1271.55(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The summary of records for HCT/Ps did not contain the address of the establishment that…
- 02
Donor eligibility records are…
This inspection in context
Michelle Paxon
3 documents · 2024–2025
Cites 1271.55(b)(2) (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 Texas.
The firmElite IVF & Fertility Solutions LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.55(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elite IVF & Fertility Solutions LLC?
FDA listed 2 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 Elite IVF & Fertility Solutions LLC?
Michelle Paxon is named on this Form 483, for the inspection of Mar 27 – Mar 28, 2025. Each investigator has a profile showing what they cite most.
When was Elite IVF & Fertility Solutions LLC inspected by FDA?
The inspection ran Mar 27 – Mar 28, 2025, and the Form 483 is dated March 28, 2025.
How do I get the full Form 483 for Elite IVF & Fertility Solutions 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.