Company
GermanyOlympus Winter & IBE Gmbh, Hamburg, Germany – FDA Inspections
Inspection records and compliance data for Olympus Winter & IBE Gmbh in Hamburg. 6 FDA inspections on record, 2 Form 483s, last inspected November 21, 2025.
Company Profile
This profile covers Olympus Winter & IBE Gmbh based in Hamburg, Germany.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected December 3, 2009. Last inspected November 21, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Acceptance status1 inspection
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1292176 |
| September 1, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1179969 |
| April 12, 2018 | Not classified | Medical Devices & Rad Health | 1078175 |
| January 26, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1002852 |
| December 4, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 909453 |
| December 3, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 634581 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Olympus Winter & IBE Gmbh
FEI Number
3002807798
Address
Kuehnstr. 61, Hamburg, Germany
Country
Germany
ID: 659febab-3d43-4252-a9d6-648bd6fe57ea