742849
Midmark Corporation — FEI 1523530
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 12, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Versailles, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |