Osteotech, Inc.
Form 483 issued December 13, 2010 · Eatontown, New Jersey
- Inspection
- Oct 6 – Dec 9, 2010
- Investigators
- Jennifer Macmillan· Sarah M. Forney
- Observations
- 10
- Pages
- 6
- FEI number
- 3002600221
In short: On December 13, 2010, FDA issued a Form 483 with 10 observations to Osteotech, Inc. in Eatontown, New Jersey (FEI 3002600221) after an inspection that ran Oct 6 – Dec 9, 2010. The investigators were Jennifer Macmillan and Sarah M. Forney. Most observations concern hCT/P and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
HCT/P and capa account for 8 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
HCT/Ps were not processed in a way that does not increase the risk of introduction, transmission…
- 02
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the manufacture…
- 03
Procedures for facility cleaning and…
- 04
Procedures to control the labeling of…
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.220(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Osteotech, Inc.?
FDA listed 10 observations on this Form 483, mostly about hCT/P, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Osteotech, Inc.?
Jennifer Macmillan and Sarah M. Forney are named on this Form 483, for the inspection of Oct 6 – Dec 9, 2010. Each investigator has a profile showing what they cite most.
When was Osteotech, Inc. inspected by FDA?
The inspection ran Oct 6 – Dec 9, 2010, and the Form 483 is dated December 13, 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.