Biograft Transplant Services Inc
Form 483 issued February 26, 2026 · Houston, Texas
- Inspection
- Feb 24 – Feb 26, 2026
- Investigator
- Mizanne E. Lewis
- Observations
- 1
- Pages
- 2
- FEI number
- 3001238010
In short: On February 26, 2026, FDA issued a Form 483 with 1 observation to Biograft Transplant Services Inc in Houston, Texas (FEI 3001238010) after an inspection that ran Feb 24 – Feb 26, 2026. The investigator was Mizanne E. Lewis. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.195 (environmental control and monitoring).
At a glance
1 of 1 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.195 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Environmental conditions were not…
This inspection in context
Mizanne E. Lewis
1 document · 2026
Cites 1271.195 (environmental control and monitoring) more than any other section. Most of their documents are for sites in Texas.
The firmBiograft Transplant Services Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.195
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biograft Transplant Services Inc?
FDA listed 1 observation on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.195 (environmental control and monitoring). The opening words of each observation are shown on this page.
Who inspected Biograft Transplant Services Inc?
Mizanne E. Lewis is named on this Form 483, for the inspection of Feb 24 – Feb 26, 2026. Each investigator has a profile showing what they cite most.
When was Biograft Transplant Services Inc inspected by FDA?
The inspection ran Feb 24 – Feb 26, 2026, and the Form 483 is dated February 26, 2026.
How do I get the full Form 483 for Biograft Transplant Services 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.