FDA Inspection 1215161 — Uniao Quimica Farmaceutica Nacional SA
The FDA completed an inspection of Uniao Quimica Farmaceutica Nacional SA on Aug 9, 2023 in Guarulhos. 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). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Guarulhos (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |