Osteotech, Inc.
FDA inspection history in Eatontown, New Jersey, 2010
- 1
- Form 483
Every document, by year
- Form 483
2010: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One Form 483, at Eatontown, New Jersey.
Cited most
Across all Osteotech observations on file
- 21 CFR 820.75(b)Process validation2
- 21 CFR 1271.160(b)(5)Establishment and maintenance of a quality program1
- 21 CFR 1271.180(a)Procedures1
- 21 CFR 1271.190(d)(1)Facilities1
- 21 CFR 1271.220(a)Processing and process controls1
The complete Osteotech file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Eatontown, New Jersey
One Form 483 · 2010 · 10 observations
Latest: Form 483, Dec 13, 2010 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2010-12-13 | 483 Form 483 | Eatontown, New Jersey | 10 | $99 |
Investigators on these documents
FEI number 3002600221 · most recent document Dec 13, 2010
About Osteotech, Inc.
How many FDA Form 483s has Osteotech, Inc. received?
FDA Intel has 1 Form 483 on file for Osteotech, Inc.; the most recent is dated Dec 13, 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 13, 2010, for the site in Eatontown, New Jersey.
What did FDA cite at Osteotech, Inc.?
The regulations cited most in the observations on file for Osteotech, Inc. are 21 CFR 820.75(b) (Process validation), 2 times; 21 CFR 1271.160(b)(5) (Establishment and maintenance of a quality program), 1 time; 21 CFR 1271.180(a) (Procedures), 1 time.