FDA Inspection
Otto Bock Healthcare LPOtto Bock Healthcare LP – FDA Inspection, Aug 24, 2026
Record Details
This FDA Inspection record concerns Otto Bock Healthcare LP, with an inspection on August 24, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Otto Bock Healthcare LP
- Inspection Date
- August 24, 2026
- Product Type
- Devices
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ID · a21bae5a-a92d-4a40-87d5-792bc83300b5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1332566
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- ISO 13485:2016 Clause 7.3.10Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.10Design and development verification not performed
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Other FDA inspections of Otto Bock Healthcare LP
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Otto Bock Healthcare LP
- FDA Inspection 1174362 - 2022-06-14
- FDA Inspection 924642 - 2015-04-24
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