FDA Inspection
Data Innovations, LLCData Innovations, LLC – FDA Inspection, Sep 1, 2016
Record Details
This FDA Inspection record concerns Data Innovations, LLC, with an inspection on September 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Data Innovations, LLC
- Inspection Date
- September 1, 2016
- Product Type
- Devices
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ID · 2d4588e6-f46e-45de-931e-e5f32a2ac4a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984891
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - software validation not performed
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