FDA Inspection
Rudolf Riester GmbhRudolf Riester Gmbh – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns Rudolf Riester Gmbh, with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ae92d9c5-4407-42f1-9641-0cd40614cf55
Inspection Facts
- Inspection number
- 1336022
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.3.5Design and development reviews not performed
- ISO 13485:2016 Clause 7.3.8Design and development transfer results or conclusions not recorded
- ISO 13485:2016 Clause 8.5.2Corrective action records not maintained
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Other FDA inspections of Rudolf Riester Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2019 | Not classified | Office of Inspections and Investigations | |
| June 24, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rudolf Riester Gmbh
- FDA Inspection 1101224 - 2019-05-16
- FDA Inspection 672689 - 2010-06-24
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