Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-04-10.
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 |
|---|---|---|---|
| 7 Apr 2015 – 10 Apr 2015 | Medical Devices & Rad Health | 483 | On file |
| 9 Apr 2010 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Michael J Nerz1 insp.
Steven R Ziser1 insp.
Full site report
Get the verbatim findings behind Orthogem Ltd's 2 Form 483s
The full inspection record, as Atlas holds it, 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