FDA Inspection
StephanixStephanix – FDA Inspection, Sep 14, 2023
Record Details
This FDA Inspection record concerns Stephanix, with an inspection on September 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d93a9f2a-859e-4175-ac12-64b26294b73f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218225
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
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