727209
Cortex Manufacturing Inc. — FEI 3008706707
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 23, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Byhalia, MS (United States)
Citations
| ID | CFR | Description |
|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |