1178833
LEC Custom Products, Inc — FEI 3012665392
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 2, 2022
- Fiscal Year
- 2022
- 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 |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |