FDA Inspection
Nico Corp.Nico Corp. – FDA Inspection, Dec 30, 2015
Record Details
This FDA Inspection record concerns Nico Corp., with an inspection on December 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nico Corp.
- Inspection Date
- December 30, 2015
- Product Type
- Devices
View Company Profile
ID · 03571fc2-61f0-4949-8d8a-12bd1da5e674
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955978
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Nico Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2018 | Not classified | Detroit District Office |
Other documents for Nico Corp.
- FDA Inspection 1108608 - 2018-10-25
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