FDA Inspection 1211696 — Catalent Argentina S.A.I.C.
The FDA completed an inspection of Catalent Argentina S.A.I.C. on August 4, 2023 in Buenos Aires. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 4, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buenos Aires (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |