Musculoskeletal Transplant Foundation
Form 483 issued January 18, 2018 · Edison, New Jersey
- Inspection
- Nov 14, 2017 – Jan 18, 2018
- Investigators
- Jennifer L. Custodio· Sarah M. Forney
- Observations
- 1
- Pages
- 2
- FEI number
- 3001236616
In short: On January 18, 2018, FDA issued a Form 483 with 1 observation to Musculoskeletal Transplant Foundation in Edison, New Jersey (FEI 3001236616) after an inspection that ran Nov 14, 2017 – Jan 18, 2018. The investigators were Jennifer L. Custodio and Sarah M. Forney. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?).
At a glance
1 of 1 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.75(a)(1) (1×)
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…
This inspection in context
Jennifer L. Custodio
1 document · 2018
Cites 1271.75(a)(1) (how do i screen a donor?) more than any other section. Most of their documents are for sites in New Jersey.
The firmMusculoskeletal Transplant Foundation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Musculoskeletal Transplant Foundation?
FDA listed 1 observation on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?). The opening words of each observation are shown on this page.
Who inspected Musculoskeletal Transplant Foundation?
Jennifer L. Custodio and Sarah M. Forney are named on this Form 483, for the inspection of Nov 14, 2017 – Jan 18, 2018. Each investigator has a profile showing what they cite most.
When was Musculoskeletal Transplant Foundation inspected by FDA?
The inspection ran Nov 14, 2017 – Jan 18, 2018, and the Form 483 is dated January 18, 2018.
How do I get the full Form 483 for Musculoskeletal Transplant Foundation?
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.