Osteotech, Inc.
Form 483 issued December 9, 2010 · Shrewsbury, New Jersey
- Inspection
- Nov 18 – Dec 9, 2010
- Investigator
- Jennifer Macmillan
- Observations
- 2
- Pages
- 2
- FEI number
- 3002277646
In short: On December 9, 2010, FDA issued a Form 483 with 2 observations to Osteotech, Inc. in Shrewsbury, New Jersey (FEI 3002277646) after an inspection that ran Nov 18 – Dec 9, 2010. The investigator was Jennifer Macmillan. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.180 (procedures).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.180(a) (1×) · 1271.265(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures were not designed to prevent circumstances that increase the risk of communicable disease introduction, transmission…
- 02
Incoming HCT/Ps were not accepted and rejected based on pre-established criteria designed to…
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 firmOsteotech, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.180(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Osteotech, Inc.?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.180 (procedures). The opening words of each observation are shown on this page.
Who inspected Osteotech, Inc.?
Jennifer Macmillan is named on this Form 483, for the inspection of Nov 18 – Dec 9, 2010. Each investigator has a profile showing what they cite most.
When was Osteotech, Inc. inspected by FDA?
The inspection ran Nov 18 – Dec 9, 2010, and the Form 483 is dated December 9, 2010.
How do I get the full Form 483 for Osteotech, Inc.?
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.