1249263
Luster Products Inc — FEI 1417123
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |