OMRIX Biopharmaceuticals Ltd.
Form 483 issued February 24, 2024 · RAMAT GAN, Israel
- Inspection
- Feb 16, 2020 – Feb 24, 2024
- Investigators
- Chava Kinkis-Sadary· Mihaly S. Ligmond· Steven E. Bowen
- Observations
- 12
- Pages
- 7
- FEI number
- 3003183625
In short: On February 24, 2024, FDA issued a Form 483 with 12 observations to OMRIX Biopharmaceuticals Ltd. in RAMAT GAN, Israel (FEI 3003183625) after an inspection that ran Feb 16, 2020 – Feb 24, 2024. The investigators were Chava Kinkis-Sadary, Mihaly S. Ligmond and Steven E. Bowen. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to receive supplement approval from FDA prior to distributing product…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Chava Kinkis-Sadary
1 document · 2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Israel.
The firmOMRIX Biopharmaceuticals Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OMRIX Biopharmaceuticals Ltd.?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected OMRIX Biopharmaceuticals Ltd.?
Chava Kinkis-Sadary, Mihaly S. Ligmond and Steven E. Bowen are named on this Form 483, for the inspection of Feb 16, 2020 – Feb 24, 2024. Each investigator has a profile showing what they cite most.
When was OMRIX Biopharmaceuticals Ltd. inspected by FDA?
The inspection ran Feb 16, 2020 – Feb 24, 2024, and the Form 483 is dated February 24, 2024.
How do I get the full Form 483 for OMRIX Biopharmaceuticals Ltd.?
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.