FDA Inspection
Otto Bock Healthcare Products GmbHOtto Bock Healthcare Products GmbH – FDA Inspection, Nov 21, 2019
Record Details
This FDA Inspection record concerns Otto Bock Healthcare Products GmbH, with an inspection on November 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 21, 2019
- Product Type
- Devices
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ID · d3413740-944d-4ec8-b65b-ec09b06ed6b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110603
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Otto Bock Healthcare Products GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2026 | Not classified | Office of Inspections and Investigations | |
| November 3, 2023 | Not classified | Office of Inspections and Investigations | |
| June 9, 2017 | Not classified | Office of Inspections and Investigations | |
| June 8, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| October 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Otto Bock Healthcare Products GmbH
- FDA Inspection 1309056 - 2026-05-29
- FDA Inspection 1228917 - 2023-11-03
- FDA Inspection 1020400 - 2017-06-09
- FDA Inspection 1014754 - 2017-06-08
- FDA Inspection 807572 - 2012-10-19
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