663897
Hightech American Industrial Laboratories, Inc. — FEI 3003046678
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lexington, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |