Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-03-17.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Mar 2022 – 17 Mar 2022 | Human Drugs | 483 | On file |
| 3 Oct 2016 – 5 Oct 2016 | Human Drugs | 483 | View 483 → |
| 6 Jan 2011 | Not recorded | Clean | |
| 9 Jul 2010 | Not recorded | 483 | View 483 → |
| 25 Feb 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Oct 2016
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Juan R Jimenez Garcia
9 Jul 2010
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Sony Mathews, Satheesh Thomas
Investigators
FDA investigators tied to this site in the record.
Sony Mathews2 insp.
Johnna L Bleem1 insp.
Tekalign Wondimu1 insp.
Tanya R Syffrard1 insp.
Juan R Jimenez Garcia1 insp.
Satheesh Thomas1 insp.
Demitria J Xiradakis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Elementis SRL, Inc.'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