FDA Inspection 1332566 — Otto Bock Healthcare LP
The FDA completed an inspection of Otto Bock Healthcare LP on Aug 24, 2026 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23114 | ISO 13485:2016 Clause 7.3.6 | Design and development verification not performed |
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |