FDA Inspection
Umicore Argentina S.A.Umicore Argentina S.A. – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns Umicore Argentina S.A., with an inspection on May 11, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 64f0a67d-b5f8-4673-b60e-7af01fd49568
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051715
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Umicore Argentina S.A.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2026 | Not classified | Office of Inspections and Investigations | |
| February 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Umicore Argentina S.A.
- FDA Inspection 1324096 - 2026-06-09
- FDA Inspection 962713 - 2016-02-26
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