FDA Inspection 1051715 — Umicore Argentina S.A.
The FDA completed an inspection of Umicore Argentina S.A. on May 11, 2018 in Pilar. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pilar (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |