Musculoskeletal Transplant Foundation
Form 483 issued May 13, 2004 · Jessup, Pennsylvania
- Inspection
- May 11 – May 13, 2004
- Investigators
- Ann Marie Karnick· Barbara D. Paul
- Observations
- 2
- Pages
- 2
- FEI number
- 1000307092
In short: On May 13, 2004, FDA issued a Form 483 with 2 observations to Musculoskeletal Transplant Foundation in Jessup, Pennsylvania (FEI 1000307092) after an inspection that ran May 11 – May 13, 2004. The investigators were Ann Marie Karnick and Barbara D. Paul. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.270 (records).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.270 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain records concurrently with the performance of each significant step in the performance of…
- 02
Records fail to be as detailed as necessary to provide a complete history of the work…
This inspection in context
Ann Marie Karnick
2 documents · 2004–2008
Cites 1271.270 (records) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMusculoskeletal Transplant Foundation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.270
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Musculoskeletal Transplant Foundation?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.270 (records). The opening words of each observation are shown on this page.
Who inspected Musculoskeletal Transplant Foundation?
Ann Marie Karnick and Barbara D. Paul are named on this Form 483, for the inspection of May 11 – May 13, 2004. Each investigator has a profile showing what they cite most.
When was Musculoskeletal Transplant Foundation inspected by FDA?
The inspection ran May 11 – May 13, 2004, and the Form 483 is dated May 13, 2004.
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.