FDA Inspection
Olympus Winter & IBE GmbhOlympus Winter & IBE Gmbh – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns Olympus Winter & IBE Gmbh, with an inspection on November 21, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Olympus Winter & IBE Gmbh
- Inspection Date
- November 21, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · dd470889-ccf8-48d3-9614-7a304ad9bc24
Inspection Facts
- Inspection number
- 1292176
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Olympus Winter & IBE Gmbh
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2018 | Not classified | Office of Inspections and Investigations | |
| January 26, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1179969 - 2022-09-01
- FDA Inspection 1078175 - 2018-04-12
- FDA Inspection 1002852 - 2017-01-26
- FDA Inspection 909453 - 2014-12-04
- FDA Inspection 634581 - 2009-12-03
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