FDA Inspection 771301 — Argenta US Manufacturing LLC
The FDA completed an inspection of Argenta US Manufacturing LLC on March 8, 2012 in Shawnee, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shawnee, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |