FDA Inspection
Olympus Winter & IBE GmbhOlympus Winter & IBE Gmbh – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Olympus Winter & IBE Gmbh, with an inspection on January 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shafiq Ahadi (Issuing Officer)
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ID · ce21d3c5-e0e3-450f-b140-a53f028ef4a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002852
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Olympus Winter & IBE Gmbh
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| September 1, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2018 | Not classified | Office of Inspections and Investigations | |
| December 4, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Olympus Winter & IBE Gmbh
- FDA Inspection 1292176 - 2025-11-21
- FDA Inspection 1179969 - 2022-09-01
- FDA Inspection 1078175 - 2018-04-12
- FDA Inspection 909453 - 2014-12-04
- FDA Inspection 634581 - 2009-12-03
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