FDA Inspection 853861 — Argenta US Manufacturing LLC
The FDA completed an inspection of Argenta US Manufacturing LLC on Nov 1, 2013 in Shawnee, KS. 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: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2013
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Shawnee, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |