Catalent Belgium SA
Form 483 issued July 12, 2024 · Brussels, Belgium
- Inspection
- Jul 3 – Jul 12, 2024
- Investigator
- Hamet Tour
- Observations
- 9
- Pages
- 7
- FEI number
- 3007647000
In short: On July 12, 2024, FDA issued a Form 483 with 9 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Jul 3 – Jul 12, 2024. The investigator was Hamet Tour. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 9 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbial contamination of drug products purporting to be sterile are…
- 02
Environmental Monitoring trending reports…
- 03
Aseptic process simulations (APS) do not fully…
- 04
The air flow pattern testing studies did not include the introduction of the lin g@@ into…
This inspection in context
Hamet Tour
2 documents · 2023–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Belgium.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Belgium SA?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Catalent Belgium SA?
Hamet Tour is named on this Form 483, for the inspection of Jul 3 – Jul 12, 2024. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Jul 3 – Jul 12, 2024, and the Form 483 is dated July 12, 2024.
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.