Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 21 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Aug 2022 – 1 Sep 2022 | Medical Devices & Rad Health | Clean | |
| 9 Apr 2018 – 12 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2017 – 26 Jan 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Dec 2014 – 4 Dec 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Dec 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2025
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Katelyn A Staub-Zamperini
21 Nov 2025
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Katelyn A Staub-Zamperini
21 Nov 2025
21 CFR 820.30(c)
Design input - Lack of or inadequate procedures
Cited by Katelyn A Staub-Zamperini
Investigators
FDA investigators tied to this site in the record.
Katelyn A Staub-Zamperini1 insp.
Marlo-Ian M Alintanahin1 insp.
MDSAP harperd1 insp.
Shafiq Ahadi1 insp.
Dennis R Hock1 insp.
Jacqueline S Warner1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Olympus Winter & IBE Gmbh's 4 Form 483s
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