Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-03-05.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2020 – 5 Mar 2020 | Biologics | 483 | View 483 → |
| 19 May 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2020
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Mihaly S Ligmond, Chava Kimchi Sarfaty, Steven E Bowen
5 Mar 2020
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Mihaly S Ligmond, Chava Kimchi Sarfaty, Steven E Bowen
5 Mar 2020
21 CFR 211.188(b)(8)
Labeling control records including specimens or copies
Cited by Mihaly S Ligmond, Chava Kimchi Sarfaty, Steven E Bowen
5 Mar 2020
21 CFR 211.194(a)(4)
Complete Test Data
Cited by Mihaly S Ligmond, Chava Kimchi Sarfaty, Steven E Bowen
Investigators
FDA investigators tied to this site in the record.
Mihaly S Ligmond1 insp.
Chava Kimchi Sarfaty1 insp.
Steven E Bowen1 insp.
Randa Melhem1 insp.
Destry M Sillivan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Omrix Biopharmaceuticals Ltd.'s 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat