MFC Lab, Inc.
Form 483 issued April 30, 2025
- Inspection
- Apr 29 – Apr 30, 2025
- Investigator
- Emily S. McGann
- Observations
- 2
- Pages
- 2
- FEI number
- 3009682116
In short: On April 30, 2025, FDA issued a Form 483 with 2 observations to MFC Lab, Inc. (FEI 3009682116) after an inspection that ran Apr 29 – Apr 30, 2025. The investigator was Emily S. McGann. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.50 (how do I determine whether a donor is eligible?).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.50 (1×) · 1271.47 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based…
- 02
You did not establish and maintain procedures for…
This inspection in context
Emily S. McGann
6 documents · 2024–2026
Cites 1271.50 (how do i determine whether a donor is eligible?) more than any other section. Most of their documents are for sites in Arizona.
The firmMFC Lab, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MFC Lab, Inc.?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.50 (how do I determine whether a donor is eligible?). The opening words of each observation are shown on this page.
Who inspected MFC Lab, Inc.?
Emily S. McGann is named on this Form 483, for the inspection of Apr 29 – Apr 30, 2025. Each investigator has a profile showing what they cite most.
When was MFC Lab, Inc. inspected by FDA?
The inspection ran Apr 29 – Apr 30, 2025, and the Form 483 is dated April 30, 2025.
How do I get the full Form 483 for MFC Lab, Inc.?
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.