1120203
LEC Custom Products, Inc. — FEI 3004737602
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 6, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brampton (Canada)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |