FDA Inspection
Dialunox GmbHDialunox GmbH – FDA Inspection, May 26, 2017
Record Details
This FDA Inspection record concerns Dialunox GmbH, with an inspection on May 26, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 91cece72-f33b-4373-a190-f98ba0afd833
Inspection Facts
- Inspection number
- 1022847
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
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