966715
W & R Investments LLC d.b.a. Laser Engineering — FEI 3009593803
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Milford, MA (United States)
Citations
| ID | CFR | Description |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |