Center for Assisted Reproduction (CARE
Form 483 issued September 10, 2025 · Bedford, Texas
- Inspection
- Sep 5 – Sep 10, 2025
- Investigator
- Elyshia Q. Danaher
- Observations
- 3
- Pages
- 4
- FEI number
- 3003926882
In short: On September 10, 2025, FDA issued a Form 483 with 3 observations to Center for Assisted Reproduction (CARE in Bedford, Texas (FEI 3003926882) after an inspection that ran Sep 5 – Sep 10, 2025. The investigator was Elyshia Q. Danaher. 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.
Most cited: 21 CFR 1271.55 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and…
- 02
You did not establish and maintain procedures that address the accompanying records after the donor eligibility…
- 03
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled with…
This inspection in context
Elyshia Q. Danaher
3 documents · 2025–2026
Cites 1271.55 (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 firmCenter for Assisted Reproduction (CARE history
The site's inspection history, in date order.
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 Center for Assisted Reproduction (CARE?
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 Center for Assisted Reproduction (CARE?
Elyshia Q. Danaher is named on this Form 483, for the inspection of Sep 5 – Sep 10, 2025. Each investigator has a profile showing what they cite most.
When was Center for Assisted Reproduction (CARE inspected by FDA?
The inspection ran Sep 5 – Sep 10, 2025, and the Form 483 is dated September 10, 2025.
How do I get the full Form 483 for Center for Assisted Reproduction (CARE?
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.