Catalent Belgium SA
Form 483 issued July 7, 2017 · Brussels, Belgium
- Inspection
- Jul 7, 2017
- Investigators
- Gene D. Arcy· Mihaly S. Ligmond
- Observations
- 7
- Pages
- 5
- FEI number
- 3007647000
In short: On July 7, 2017, FDA issued a Form 483 with 7 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Jul 7, 2017. The investigators were Gene D. Arcy and Mihaly S. Ligmond. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Access to the storage area for labels and labeling materials is not…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCatalent Belgium SA history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Belgium SA?
FDA listed 7 observations on this Form 483, mostly about production, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Catalent Belgium SA?
Gene D. Arcy and Mihaly S. Ligmond are named on this Form 483, for the inspection of Jul 7, 2017. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Jul 7, 2017, and the Form 483 is dated July 7, 2017.
How do I get the full Form 483 for Catalent Belgium SA?
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.