Musculoskeletal Transplant Foundation
Form 483 issued March 13, 2009 · Edison, New Jersey
- Inspection
- Jan 27 – Mar 13, 2009
- Investigators
- Dawn L. Wydner· Juanita P. Versace· Sarah M. Forney
- Observations
- 7
- Pages
- 5
- FEI number
- 3001236616
In short: On March 13, 2009, FDA issued a Form 483 with 7 observations to Musculoskeletal Transplant Foundation in Edison, New Jersey (FEI 3001236616) after an inspection that ran Jan 27 – Mar 13, 2009. The investigators were Dawn L. Wydner, Juanita P. Versace, Sarah M. Forney and Susan T. Hadman. Most observations concern hCT/P and production & process controls.
At a glance
5 of 7 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
Written representation that processing methods reduce the risk of transmission of communicable disease by HCT/Ps was…
- 02
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination…
- 03
Specified requirements for in-process…
- 04
You did not ensure that establishment(s) that by contract, agreement or arrangement, perform manufacturing steps for…
This inspection in context
Dawn L. Wydner
1 document · 2009
Cites 1271.150(c)(1)(iii) (current good tissue practice requirements) 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 1271.230(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Musculoskeletal Transplant Foundation?
FDA listed 7 observations on this Form 483, mostly about hCT/P, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Musculoskeletal Transplant Foundation?
Dawn L. Wydner, Juanita P. Versace, Sarah M. Forney and Susan T. Hadman are named on this Form 483, for the inspection of Jan 27 – Mar 13, 2009. Each investigator has a profile showing what they cite most.
When was Musculoskeletal Transplant Foundation inspected by FDA?
The inspection ran Jan 27 – Mar 13, 2009, and the Form 483 is dated March 13, 2009.
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.