Osteotech, Inc.
Form 483 issued December 14, 2007 · Shrewsbury, New Jersey
- Inspection
- Dec 3 – Dec 14, 2007
- Investigator
- Neil D. Guerin
- Observations
- 3
- Pages
- 3
- FEI number
- 3002277646
In short: On December 14, 2007, FDA issued a Form 483 with 3 observations to Osteotech, Inc. in Shrewsbury, New Jersey (FEI 3002277646) after an inspection that ran Dec 3 – Dec 14, 2007. The investigator was Neil D. Guerin. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.265 (receipt, predistribution shipment, and distribution of an HCT/P).
At a glance
3 of 3 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.265 (2×) · 1271.290 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Incoming HCT/Ps were not accepted and rejected based on pre-established criteria designed to…
- 02
When new identification codes are assigned to HCT/Ps used at this establishment in place of distinct…
- 03
Documentation for activities related to the shipment and distribution of HCT/Ps did not include activities performed…
This inspection in context
Neil D. Guerin
1 document · 2007
Cites 1271.265 (receipt, predistribution shipment, and distribution of an hct/p) 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 1271.265
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Osteotech, Inc.?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.265 (receipt, predistribution shipment, and distribution of an HCT/P). The opening words of each observation are shown on this page.
Who inspected Osteotech, Inc.?
Neil D. Guerin is named on this Form 483, for the inspection of Dec 3 – Dec 14, 2007. Each investigator has a profile showing what they cite most.
When was Osteotech, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 14, 2007, and the Form 483 is dated December 14, 2007.
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.