Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-09.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Jun 2026 – 9 Jun 2026 | Human Drugs | 483 | On file |
| 7 May 2018 – 11 May 2018 | Human Drugs | 483 | View 483 → |
| 23 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 May 2018
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Santos E Camara
11 May 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Santos E Camara
11 May 2018
21 CFR 211.194(c)
Testing and standardization of standards et. al.
Cited by Santos E Camara
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Umicore Argentina S.A.'s 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat