FDA Inspection
Rudolf Storz GmbHRudolf Storz GmbH – FDA Inspection, Sep 25, 2025
Record Details
This FDA Inspection record concerns Rudolf Storz GmbH, with an inspection on September 25, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 897ca4e4-9784-424b-8529-1d0b7dfc0bd0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1284368
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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