Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-01.
At a glance
Inspections
12
Form 483s
5
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jan 2024 – 1 Feb 2024 | Human Drugs | Clean | |
| 17 Apr 2023 – 21 Apr 2023 | Human Drugs | 483 | On file |
| 27 Jan 2022 – 4 Feb 2022 | Human Drugs | 483 | On file |
| 23 Nov 2021 – 25 Nov 2021 | Human Drugs | Clean | |
| 20 Jan 2017 – 27 Jan 2017 | Human Drugs | 483 | On file |
| 17 Mar 2016 – 23 Mar 2016 | Human Drugs | 483 | On file |
| 3 Sep 2015 – 11 Sep 2015 | Human Drugs | Clean | |
| 9 Dec 2014 – 16 Dec 2014 | Human Drugs | 483 | View 483 → |
| 1 Jul 2011 | Not recorded | Clean | |
| 16 Jan 2008 | Not recorded | Clean | |
| 22 Dec 2005 | Not recorded | Clean | |
| 28 Mar 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2014
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jose E Melendez
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen2 insp.
MRA M BarbosaR1 insp.
Alice S Tsao1 insp.
Madushini N Dharmasena1 insp.
Hamet M Toure1 insp.
Roger F Zabinski1 insp.
Wayne E Seifert1 insp.
MRA McCulloughJ1 insp.
Simone E Pitts1 insp.
Jacqueline M Diaz Albert1 insp.
Ephrem T Hunde1 insp.
Zhihao Pete Qiu1 insp.
Tracey L Harris1 insp.
Jose E Melendez1 insp.
Uduak M Inokon1 insp.
Azza Talaat1 insp.
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 |
Full site report
Get the verbatim findings behind UCB Pharma S.A.'s 5 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