Osteotech, Inc.
FDA inspection history in Shrewsbury, New Jersey, 2007 to 2010
- 2
- Form 483s
Every document, by year
- Form 483
2007: one Form 483; 2010: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2007One Form 483, at Shrewsbury, New Jersey.
- 2007The longest 483 on file: 3 observations over 3 pages at Shrewsbury, New Jersey.
- 2010One Form 483, at Shrewsbury, New Jersey.
Cited most
Across all Osteotech observations on file
- 21 CFR 1271.265Receipt, predistribution shipment, and distribution of an HCT/P3
- 21 CFR 1271.180(a)Procedures1
- 21 CFR 1271.290Tracking1
The complete Osteotech file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Shrewsbury, New Jersey
Two Form 483s · 2007 to 2010 · 5 observations
Latest: Form 483, Dec 9, 2010 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2010-12-09 | 483 Form 483 | Shrewsbury, New Jersey | 2 | $99 |
| 2007-12-14 | 483 Form 483 | Shrewsbury, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 3002277646 · most recent document Dec 9, 2010
About Osteotech, Inc.
How many FDA Form 483s has Osteotech, Inc. received?
FDA Intel has 2 Form 483s on file for Osteotech, Inc.; the most recent is dated Dec 9, 2010.
When was Osteotech, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Osteotech, Inc. is a Form 483 dated Dec 9, 2010, for the site in Shrewsbury, New Jersey.
What did FDA cite at Osteotech, Inc.?
The regulations cited most in the observations on file for Osteotech, Inc. are 21 CFR 1271.265 (Receipt, predistribution shipment, and distribution of an HCT/P), 3 times; 21 CFR 1271.180(a) (Procedures), 1 time; 21 CFR 1271.290 (Tracking), 1 time.