Omrix Biopharmaceuticals Ltd.
Form 483 issued March 5, 2020 · Rehovot, Israel
- Inspection
- Feb 25 – Mar 5, 2020
- Investigator
- Steven E. Bowen
- Observations
- 4
- Pages
- 4
- FEI number
- 3008640339
In short: On March 5, 2020, FDA issued a Form 483 with 4 observations to Omrix Biopharmaceuticals Ltd. in Rehovot, Israel (FEI 3008640339) after an inspection that ran Feb 25 – Mar 5, 2020. The investigator was Steven E. Bowen. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Established laboratory control mechanisms are not documented at…
- 04
Batch production and control records do not include complete labeling control records, including specimens or copies…
This inspection in context
Steven E. Bowen
6 documents · 2019–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Israel.
The firmOmrix Biopharmaceuticals Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Omrix Biopharmaceuticals Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Omrix Biopharmaceuticals Ltd.?
Steven E. Bowen is named on this Form 483, for the inspection of Feb 25 – Mar 5, 2020. Each investigator has a profile showing what they cite most.
When was Omrix Biopharmaceuticals Ltd. inspected by FDA?
The inspection ran Feb 25 – Mar 5, 2020, and the Form 483 is dated March 5, 2020.
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.