FDA Inspection
Microcopy, Div. Neo-Flo, Inc.Microcopy, Div. Neo-Flo, Inc. – FDA Inspection, May 17, 2016
Record Details
This FDA Inspection record concerns Microcopy, Div. Neo-Flo, Inc., with an inspection on May 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 17, 2016
- Product Type
- Devices
View Company Profile
ID · c8568ba0-5afd-42e1-85e4-ed12897268b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971489
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.100(a)Lack of or inadequate procedures
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