OMRIX Biopharmaceuticals Ltd.
FDA inspection history in RAMAT GAN, Israel, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at RAMAT GAN, Israel.
Cited most
Across all OMRIX Biopharmaceuticals observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete OMRIX Biopharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
RAMAT GAN, Israel
One Form 483 · 2024 · 12 observations
Latest: Form 483, Feb 24, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-24 | 483 Form 483 | RAMAT GAN, Israel | 12 | $99 |
Investigators on these documents
Chava Kinkis-Sadary (1)Mihaly S. Ligmond (1)Steven E. Bowen (1)
FEI number 3003183625 · most recent document Feb 24, 2024
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 Feb 24, 2024.
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 Feb 24, 2024, for the site in RAMAT GAN, 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 (General requirements), 2 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.