803083
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC — FEI 1000119795
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cortlandt Manor, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |