FDA Inspection
2k Innovations Inc.2k Innovations Inc. – FDA Inspection, Apr 12, 2016
Record Details
This FDA Inspection record concerns 2k Innovations Inc., with an inspection on April 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 2k Innovations Inc.
- Inspection Date
- April 12, 2016
- Product Type
- Devices
View Company Profile
ID · 85542694-7372-4ccf-a2e9-b92554cf6569
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965932
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(j)Design history file
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