FDA Inspection
Kids II, IncKids II, Inc – FDA Inspection, Apr 18, 2019
Record Details
This FDA Inspection record concerns Kids II, Inc, with an inspection on April 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 76f16978-73bf-4457-8424-bd87eb0a93c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087010
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(e)Maintained
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