FDA Inspection 1098756 — Argenta US Manufacturing LLC
The FDA completed an inspection of Argenta US Manufacturing LLC on August 1, 2019 in Shawnee, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Shawnee, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |