760969
ROMD, LLC — FEI 3008959459
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 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 |