Company
GermanyOlympus Winter & Ibe GmbH, Teltow, Germany – FDA Inspections
Inspection records and compliance data for Olympus Winter & Ibe GmbH in Teltow. 3 FDA inspections on record (1 OAI), last inspected April 27, 2018.
Company Profile
This profile covers Olympus Winter & Ibe GmbH based in Teltow, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 19, 2012. Last inspected April 27, 2018.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of System for Event Evaluations1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 27, 2018 | Not classified | Medical Devices & Rad Health | 1077812 |
| January 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 915517 |
| January 19, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 771411 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Olympus Winter & Ibe GmbH
FEI Number
3003724334
Address
Berlin Facility, Rheinstr. 8, Teltow, Germany
Country
Germany
ID: 567156e5-83c9-4147-9384-a2e7a3b2221f