Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-08.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 8 May 2026 | Human Drugs | 483 | On file |
| 28 Oct 2019 – 5 Nov 2019 | Human Drugs | 483 | View 483 → |
| 14 May 2018 – 22 May 2018 | Human Drugs | 483 | View 483 → |
| 14 Nov 2016 – 23 Nov 2016 | Human Drugs | 483 | On file |
| 29 Feb 2016 – 3 Mar 2016 | Human Drugs | Clean | |
| 26 May 2014 – 3 Jun 2014 | Human Drugs | 483 | On file |
| 26 Jan 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez1 insp.
Liming Zhang1 insp.
Santos E Camara1 insp.
Juan R Jimenez Garcia1 insp.
Parul M Patel1 insp.
Maria P Kelly-Doggett1 insp.
Javier O Vega1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eriochem SA's 5 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