FDA Inspection
Vivonic GmbHVivonic GmbH – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Vivonic GmbH, with an inspection on May 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3b4aa7c2-7fe4-46aa-89a5-ebc1fbf3bb3a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017154
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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