890465
Customed, Inc. — FEI 2648727
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 31, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fajardo, PR (United States)
Citations
| ID | CFR | Description |
|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3138 | 21 CFR 820.130 | Packaging |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |