Musculoskeletal Transplant Foundation
Form 483 issued May 19, 2014 · Edison, New Jersey
- Inspection
- Mar 17 – May 19, 2014
- Investigators
- Jennifer Macmillan· Sarah M. Forney
- Observations
- 13
- Pages
- 7
- FEI number
- 3001236616
In short: On May 19, 2014, FDA issued a Form 483 with 13 observations to Musculoskeletal Transplant Foundation in Edison, New Jersey (FEI 3001236616) after an inspection that ran Mar 17 – May 19, 2014. The investigators were Jennifer Macmillan and Sarah M. Forney. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.350 (reporting).
At a glance
13 of 13 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.350(a)(1) (2×)
What FDA observed
Preview: the opening words of each observation- 01
HCT!Ps were not processed in a way that does not cause contamination or cross contamination during…
- 02
Labeling procedures were not designed to ensure proper HCTIP identi fication and…
- 03
The quality program has not ensured that appropriate corrective actions relating to core CGTP requirements are…
- 04
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture…
This inspection in context
Jennifer Macmillan
3 documents · 2010–2014
Cites 1271.350(a)(1) (reporting) 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 1271.350(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 13 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.350 (reporting). The opening words of each observation are shown on this page.
Who inspected Musculoskeletal Transplant Foundation?
Jennifer Macmillan and Sarah M. Forney are named on this Form 483, for the inspection of Mar 17 – May 19, 2014. Each investigator has a profile showing what they cite most.
When was Musculoskeletal Transplant Foundation inspected by FDA?
The inspection ran Mar 17 – May 19, 2014, and the Form 483 is dated May 19, 2014.
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.