FDA Inspection
Otto Bock Healthcare Products GmbHOtto Bock Healthcare Products GmbH – FDA Inspection, Oct 17, 2012
Record Details
This FDA Inspection record concerns Otto Bock Healthcare Products GmbH, with an inspection on October 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 17, 2012
- Product Type
- Devices
View Company Profile
ID · a0228759-49d2-4e91-9fda-4f8652686614
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807571
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - 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 | |
| June 8, 2017 | Not classified | Office of Inspections and Investigations | 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 1014754 - 2017-06-08
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