FDA Inspection
Amico Diagnostic IncorporatedAmico Diagnostic Incorporated – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns Amico Diagnostic Incorporated, with an inspection on October 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9b22d5f4-bd91-4f0d-a329-80c1064303b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995624
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(g)Design validation - documentation
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