1103191
LEC Custom Products, Inc — FEI 3012665392
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |