FDA Inspection 919491 — MIM Software Inc
The FDA completed an inspection of MIM Software Inc on Mar 27, 2015 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |