Form 483 · FEI 3007268508
Form 483 issued April 24, 2025 · Fort Worth, Texas
- Inspection
- Apr 15 – Apr 24, 2025
- Investigator
- Michelle Paxon
- Observations
- 5
- Pages
- 7
- FEI number
- 3007268508
In short: On April 24, 2025, FDA issued a Form 483 with 5 observations to an FDA-inspected site in Fort Worth, Texas (FEI 3007268508) after an inspection that ran Apr 15 – Apr 24, 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
5 of 5 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
Donors were not screened by a review of relevant medical records for risk factors and clinical…
- 02
The eligibility of an HCT/P donor was not determined by a responsible person, based on results…
- 03
The summary of records for HCT/Ps did not contain a listing and an interpretation of results…
- 0421 CFR 1271.90(c)
HCT/Ps for which the donor eligibility determination was not required and applicable donor eligibility requirements were…
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 firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.75(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 5 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 an FDA-inspected site?
Michelle Paxon is named on this Form 483, for the inspection of Apr 15 – Apr 24, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Apr 15 – Apr 24, 2025, and the Form 483 is dated April 24, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.