FDA Inspection 1192756 — Argenta US Manufacturing LLC
The FDA completed an inspection of Argenta US Manufacturing LLC on Dec 14, 2022 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: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shawnee, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |