FDA Inspection
MIM Software IncMIM Software Inc – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns MIM Software Inc, with an inspection on March 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MIM Software Inc
- Inspection Date
- March 27, 2015
- Product Type
- Devices
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ID · 3b902144-effd-4cd0-9f20-83d961054311
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919491
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of MIM Software Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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