1059751
Laboratorios Le Roy, S.A. de C.V. — FEI 3000256895
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yecapixtla (Mexico)
Citations
| ID | CFR | Description |
|---|
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |