FDA Inspection 1110198 — Suarko SRL
The FDA completed an inspection of Suarko SRL on November 15, 2019 in Bernal Oeste. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2019
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bernal Oeste (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 18201 | 21 CFR 507.19(a) | Plant Maintenance |
| 21298 | 21 CFR 507.31(a) | Food Safety Plan |
| 21343 | 21 CFR 507.202(b) | Requirements Included on Record |