FDA Inspection 881348 — Catalent Argentina S.A.I.C.
The FDA completed an inspection of Catalent Argentina S.A.I.C. on May 16, 2014 in Buenos Aires. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buenos Aires (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |