1097421
Highland Industries,Inc. — FEI 3000145316
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cheraw, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |