Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-10.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jan 2024 – 10 Jan 2024 | Medical Devices & Rad Health | Clean | |
| 5 Dec 2022 – 9 Dec 2022 | Medical Devices & Rad Health | 483 | On file |
| 6 May 2019 – 9 May 2019 | Medical Devices & Rad Health | Clean | |
| 20 Aug 2014 – 22 Aug 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jenny L Chisem1 insp.
Elizabeth A Dakan1 insp.
Vicky L Cruz1 insp.
Juanj N Wu1 insp.
Juanj Wu1 insp.
Angela Shepas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Integrated Orbital Implants Inc.'s 2 Form 483s
Source PDFs, verbatim observations, 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