Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-29.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 May 2026 – 29 May 2026 | Medical Devices & Rad Health | Clean | |
| 30 Oct 2023 – 3 Nov 2023 | Medical Devices & Rad Health | Clean | |
| 18 Nov 2019 – 21 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jun 2017 – 8 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Oct 2012 | Not recorded | 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.
Monica C Burgos Garcia1 insp.
Sean T Creighton1 insp.
John A Sciacchitano1 insp.
Catherine J Laufmann1 insp.
Dorothy W Lee1 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 | 7x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Otto Bock Healthcare Products GmbH's 3 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