FDA Inspection 1059751 — Laboratorios Le Roy, S.A. De C.V.
The FDA completed an inspection of Laboratorios Le Roy, S.A. De C.V. on Jul 20, 2018 in Yecapixtla. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 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 |