FDA Inspection 832691 — Argenta US Manufacturing LLC
The FDA completed an inspection of Argenta US Manufacturing LLC on May 21, 2013 in Shawnee, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Shawnee, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |