UCB Pharma SA Chemin du Foriest
Form 483 issued April 21, 2023 · Braine-l’Alleud, Belgium
- Inspection
- Apr 17 – Apr 21, 2023
- Investigators
- Alice S. Tsao· Hamet Tour
- Observations
- 2
- Pages
- 3
- FEI number
- 3003909356
In short: On April 21, 2023, 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 Apr 17 – Apr 21, 2023. The investigators were Alice S. Tsao and Hamet Tour. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Quality Unit failed to establish adequate document control of the forms that are…
- 02
The environmental and personnel monitoring are inadequate in classified areas. a. Swab sampling after filling of”…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.22
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 quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected UCB Pharma SA Chemin du Foriest?
Alice S. Tsao and Hamet Tour are named on this Form 483, for the inspection of Apr 17 – Apr 21, 2023. Each investigator has a profile showing what they cite most.
When was UCB Pharma SA Chemin du Foriest inspected by FDA?
The inspection ran Apr 17 – Apr 21, 2023, and the Form 483 is dated April 21, 2023.
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.