Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-04.
At a glance
Inspections
6
Form 483s
3
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Jun 2023 – 4 Jul 2023 | Human Drugs | 483 | On file |
| 23 Apr 2018 – 30 Apr 2018 | Human Drugs | Clean | |
| 16 Nov 2015 – 20 Nov 2015 | Human Drugs | 483 | On file |
| 17 Nov 2014 – 21 Nov 2014 | Human Drugs | Clean | |
| 2 Sep 2011 | Not recorded | 483 | View 483 → |
| 10 Jul 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Joanne E King, Luis M Burgos Medero
2 Sep 2011
21 CFR 211.101(d)
Component addition checked by 2nd person
Cited by Joanne E King, Luis M Burgos Medero
Investigators
FDA investigators tied to this site in the record.
Arsen Karapetyan1 insp.
Stephen D Brown1 insp.
Thuy T Nguyen1 insp.
Reyes Candau-Chacon1 insp.
Junho Pak1 insp.
Nebil A Oumer1 insp.
Joanne E King1 insp.
Luis M Burgos Medero1 insp.
James P Stumpff1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind UCB Farchim S.A.'s 3 Form 483s
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