Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-01.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Oct 2022 – 1 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 9 Jan 2018 – 17 Jan 2018 | Medical Devices & Rad Health | Clean | |
| 28 Nov 2017 – 29 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 4 Feb 2009 | Not recorded | Clean | |
| 5 Sep 2008 | Not recorded | 483 | On file |
| 13 Jun 2008 | Not recorded | Clean | |
| 23 May 2008 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Kirtida Patel2 insp.
Kelvin Cheung2 insp.
Diane C Van Leeuwen1 insp.
Cntrctmntr Anderson1 insp.
Alexandra B Pitkin1 insp.
Full site report
Get the verbatim findings behind TherOx, Inc.'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