FDA Inspection 1034510 — LEC Custom Products, Inc.
The FDA completed an inspection of LEC Custom Products, Inc. on December 8, 2017 in Brampton. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 8, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brampton (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |