FDA Inspection
viO HealthTech LimitedviO HealthTech Limited – FDA Inspection, Mar 14, 2018
Record Details
This FDA Inspection record concerns viO HealthTech Limited, with an inspection on March 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e8de9109-dcec-4a68-a79b-7247952e079d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046507
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
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