FDA Inspection
GEBRUDER RENGGLI, AGGEBRUDER RENGGLI, AG – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns GEBRUDER RENGGLI, AG, with an inspection on August 27, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 098051b2-c606-4e84-9dbf-8da2f7c33500
Inspection Facts
- Inspection number
- 1334418
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 8.2.5Actions not taken when QMS processes failed to meet planned results
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of GEBRUDER RENGGLI, AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GEBRUDER RENGGLI, AG
- FDA Inspection 1243533 - 2024-06-06
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