FDA Inspection
Olympus Winter & Ibe GmbHOlympus Winter & Ibe GmbH – FDA Inspection, Jan 19, 2012
Record Details
This FDA Inspection record concerns Olympus Winter & Ibe GmbH, with an inspection on January 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Olympus Winter & Ibe GmbH
- Inspection Date
- January 19, 2012
- Product Type
- Devices
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ID · cd4257fa-e40f-4d53-aef7-e157194ac29e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 771411
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Olympus Winter & Ibe GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2018 | Not classified | Office of Inspections and Investigations | |
| January 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Olympus Winter & Ibe GmbH
- FDA Inspection 1077812 - 2018-04-27
- FDA Inspection 915517 - 2015-01-29
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