Atlas

FDA-Inspected Site

UCB Pharma S.A.

13 FDA inspections are on record for UCB Pharma S.A. in Braine-L'Alleud, Belgium.

483· Form 483 issued

Braine-L'Alleud, Belgium · Last updated August 15, 2026

Overview

  • 13 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-04.

At a glance

Inspections

13

Form 483s

6

EIRs

4

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jun 2026 – 4 Jun 2026Medical Devices & Rad Health483View 483 →
30 Jan 2024 – 1 Feb 2024Human DrugsClean
17 Apr 2023 – 21 Apr 2023Human Drugs483On file
27 Jan 2022 – 4 Feb 2022Human Drugs483On file
23 Nov 2021 – 25 Nov 2021Human DrugsClean
20 Jan 2017 – 27 Jan 2017Human Drugs483On file
17 Mar 2016 – 23 Mar 2016Human Drugs483On file
3 Sep 2015 – 11 Sep 2015Human DrugsClean
9 Dec 2014 – 16 Dec 2014Human Drugs483View 483 →
1 Jul 2011Not recordedClean
16 Jan 2008Not recordedClean
22 Dec 2005Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

4 Jun 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Joshua J Silvestri

4 Jun 2026
ISO 13485:2016 Clause 8.5.2

Corrective action procedures not documented

Cited by Joshua J Silvestri

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.
Joshua J Silvestri1 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.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind UCB Pharma S.A.'s 6 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