FDA Inspection
Novosource IncNovosource Inc – FDA Inspection, Mar 28, 2014
Record Details
This FDA Inspection record concerns Novosource Inc, with an inspection on March 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Novosource Inc
- Inspection Date
- March 28, 2014
- Product Type
- Devices
View Company Profile
ID · 57a2cd75-6e96-4dd3-ae2a-709d51a2b8a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872455
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
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