Company
AustriaOtto Bock Healthcare Products GmbH, Vienna, Austria – FDA Inspections
Inspection records and compliance data for Otto Bock Healthcare Products GmbH in Vienna. 7 FDA inspections on record, 1 Form 483, last inspected May 29, 2026.
Company Profile
This profile covers Otto Bock Healthcare Products GmbH based in Vienna, Austria.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected October 17, 2012. Last inspected May 29, 2026.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 29, 2026 | Not classified | Medical Devices & Rad Health | 1309056 |
| November 3, 2023 | Not classified | Medical Devices & Rad Health | 1228917 |
| November 21, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1110603 |
| June 9, 2017 | Not classified | Medical Devices & Rad Health | 1020400 |
| June 8, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1014754 |
| October 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 807572 |
| October 17, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 807571 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Otto Bock Healthcare Products GmbH
FEI Number
3005190268
Address
Brehmstrase 16, Vienna, Austria
Country
Austria
ID: 105e3de1-6bd3-42cd-bf27-dbc59a6d63a9