UCB Pharma SA Chemin du Foriest
Form 483 issued January 27, 2017 · Braine-l'Alleud, Belgium
- Inspection
- Jan 19 – Jan 27, 2017
- Investigators
- Cua Ata Lagatuu· Et Ez· Simone E. Pitts
- Observations
- 8
- Pages
- 4
- FEI number
- 3003909356
In short: On January 27, 2017, FDA issued a Form 483 with 8 observations to UCB Pharma SA Chemin du Foriest in Braine-l'Alleud, Belgium (FEI 3003909356) after an inspection that ran Jan 19 – Jan 27, 2017. The investigators were Cua Ata Lagatuu, Et Ez and Simone E. Pitts. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 8 observations.
Most cited: 21 CFR 211.160 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
An investigation into the root cause of objectionable microorganisms including molds are not initiated when recovered…
This inspection in context
Cua Ata Lagatuu
1 document · 2017
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Belgium.
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 211.160
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 8 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected UCB Pharma SA Chemin du Foriest?
Cua Ata Lagatuu, Et Ez and Simone E. Pitts are named on this Form 483, for the inspection of Jan 19 – Jan 27, 2017. 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 19 – Jan 27, 2017, and the Form 483 is dated January 27, 2017.
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.