FDA Inspection 809894 — Midbrook Inc.
The FDA completed an inspection of Midbrook Inc. on November 21, 2012 in Jackson, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 21, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jackson, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |