FDA Inspection
Intio IncIntio Inc – FDA Inspection, Jan 18, 2013
Record Details
This FDA Inspection record concerns Intio Inc, with an inspection on January 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Intio Inc
- Inspection Date
- January 18, 2013
- Product Type
- Devices
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ID · 2f8c2015-de23-4a86-8fa3-01f7c2469ec0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820040
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.130Packaging
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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