Atlas

Form 483

UCB Pharma S.A. Form 483, 2026-06-04

FDA issued a Form 483 to UCB Pharma S.A. on 2026-06-04 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

UCB Pharma S.A. · Braine-L'Alleud, Belgium · Issued June 4, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

UPUCB Pharma S.A.Braine-L'Alleud, Belgium

Inspection team

JJJoshua J Silvestri

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere