Omrix Biopharmaceuticals Ltd.
FDA inspection history in Rehovot, Israel, 2004 to 2020
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter.
- 2020One Form 483, at Rehovot, Israel.
Cited most
Across all Omrix Biopharmaceuticals observations on file
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.188(b)(8)Batch production and control records1
- 21 CFR 211.194(a)(4)Laboratory records1
The complete Omrix Biopharmaceuticals 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
Rehovot, Israel
One Form 483 · 2020 · 4 observations
Latest: Form 483, Mar 5, 2020 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-05 | 483 Form 483 | Rehovot, Israel | 4 | $99 |
| 2004-05-27 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3008640339 · most recent document Mar 5, 2020
About Omrix Biopharmaceuticals Ltd.
How many FDA Form 483s has Omrix Biopharmaceuticals Ltd. received?
FDA Intel has 1 Form 483 on file for Omrix Biopharmaceuticals Ltd.; the most recent is dated Mar 5, 2020.
When was Omrix Biopharmaceuticals Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Omrix Biopharmaceuticals Ltd. is a Form 483 dated Mar 5, 2020, for the site in Rehovot, Israel.
What did FDA cite at Omrix Biopharmaceuticals Ltd.?
The regulations cited most in the observations on file for Omrix Biopharmaceuticals Ltd. are 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.188(b)(8) (Batch production and control records), 1 time; 21 CFR 211.194(a)(4) (Laboratory records), 1 time.
Has Omrix Biopharmaceuticals Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Omrix Biopharmaceuticals Ltd.; the most recent is dated May 27, 2004.