UCB Pharma SA Chemin du Foriest
Form 483 issued February 4, 2022 · Braine-l'Alleud, Belgium
- Inspection
- Jan 27 – Feb 4, 2022
- Investigators
- Roger F. Zabinski· Wayne Seifert
- Observations
- 2
- Pages
- 2
- FEI number
- 3003909356
In short: On February 4, 2022, FDA issued a Form 483 with 2 observations to UCB Pharma SA Chemin du Foriest in Braine-l'Alleud, Belgium (FEI 3003909356) after an inspection that ran Jan 27 – Feb 4, 2022. The investigators were Roger F. Zabinski and Wayne Seifert. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish process controls designed to assure that the drug product you manufacture has the…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmUCB Pharma SA Chemin du Foriest history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UCB Pharma SA Chemin du Foriest?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected UCB Pharma SA Chemin du Foriest?
Roger F. Zabinski and Wayne Seifert are named on this Form 483, for the inspection of Jan 27 – Feb 4, 2022. Each investigator has a profile showing what they cite most.
When was UCB Pharma SA Chemin du Foriest inspected by FDA?
The inspection ran Jan 27 – Feb 4, 2022, and the Form 483 is dated February 4, 2022.
How do I get the full Form 483 for UCB Pharma SA Chemin du Foriest?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.