FDA Inspection
CARDINAL HEALTH GERMANYCARDINAL HEALTH GERMANY – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns CARDINAL HEALTH GERMANY, with an inspection on September 24, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- CARDINAL HEALTH GERMANY
- Inspection Date
- September 24, 2026
- Product Type
- Medical Devices & Rad Health
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ID · c28dcef5-2d1a-438c-8d43-ae097572c46f
Inspection Facts
- Inspection number
- 1338224
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
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