FDA Inspection 1222907 — Distribuidora Comercial Jafra S.A. De C.V.
The FDA completed an inspection of Distribuidora Comercial Jafra S.A. De C.V. on Nov 17, 2023 in Santa Rosa Jauregui. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 17, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Rosa Jauregui (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 3573 | 21 CFR 211.101(b) | Measured components for manufacturing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |