FDA Inspection
Now Diagnostics IncNow Diagnostics Inc – FDA Inspection, Aug 9, 2018
Record Details
This FDA Inspection record concerns Now Diagnostics Inc, with an inspection on August 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f88f6c7a-1a49-4380-aba2-3f73ab4be9af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061836
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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