Musculoskeletal Transplant Foundation
Form 483 issued October 26, 2006 · Syracuse, New York
- Inspection
- Oct 16 – Oct 26, 2006
- Investigator
- Russ E. Davis
- Observations
- 6
- Pages
- 2
- FEI number
- 3000718045
In short: On October 26, 2006, FDA issued a Form 483 with 6 observations to Musculoskeletal Transplant Foundation in Syracuse, New York (FEI 3000718045) after an inspection that ran Oct 16 – Oct 26, 2006. The investigator was Russ E. Davis. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.200 (equipment).
At a glance
6 of 6 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.200 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documentation of facility cleaning and sanitation…
- 02
Documentation of equipment maintenance, cleaning, sanitization, and…
- 03
Equipment used for manufacturing HCT/Ps was not maintained…
- 04
Procedures for the cleaning and sanitizing of equipment were…
This inspection in context
Russ E. Davis
1 document · 2006
Cites 1271.200 (equipment) more than any other section. Most of their documents are for sites in New York.
The firmMusculoskeletal Transplant Foundation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.200
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Musculoskeletal Transplant Foundation?
FDA listed 6 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.200 (equipment). The opening words of each observation are shown on this page.
Who inspected Musculoskeletal Transplant Foundation?
Russ E. Davis is named on this Form 483, for the inspection of Oct 16 – Oct 26, 2006. Each investigator has a profile showing what they cite most.
When was Musculoskeletal Transplant Foundation inspected by FDA?
The inspection ran Oct 16 – Oct 26, 2006, and the Form 483 is dated October 26, 2006.
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.