FDA Inspection
UCB Pharma S.A.UCB Pharma S.A. – FDA Inspection, Jun 4, 2026
Record Details
This FDA Inspection record concerns UCB Pharma S.A., with an inspection on June 4, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · fb6ef372-1365-40fa-85fa-7cf1948da79c
Inspection Facts
- Inspection number
- 1323186
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UCB Pharma S.A.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2023 | Not classified | Office of Inspections and Investigations | |
| November 25, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 11, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for UCB Pharma S.A.
- FDA Inspection 1247808 - 2024-02-01
- FDA Inspection 1208307 - 2023-04-21
- FDA Inspection 1170317 - 2021-11-25
- FDA Inspection 1013309 - 2017-01-27
- FDA Inspection 946302 - 2015-09-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.