FDA Inspection
Otto Bock Healthcare Products GmbHOtto Bock Healthcare Products GmbH – FDA Inspection, Jun 8, 2017
Record Details
This FDA Inspection record concerns Otto Bock Healthcare Products GmbH, with an inspection on June 8, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 8, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · cf81c385-54a3-41ba-8a1f-64f56c36227b
Inspection Facts
- Inspection number
- 1014754
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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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 | |
| November 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 9, 2017 | Not classified | Office of Inspections and Investigations | |
| 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 1110603 - 2019-11-21
- FDA Inspection 1020400 - 2017-06-09
- FDA Inspection 807572 - 2012-10-19
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