Catalent Belgium SA
Form 483 issued June 19, 2019 · Brussels, Belgium
- Inspection
- Jun 11 – Jun 19, 2019
- Investigator
- Mihaly S. Ligmond
- Observations
- 3
- Pages
- 3
- FEI number
- 3007647000
In short: On June 19, 2019, FDA issued a Form 483 with 3 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Jun 11 – Jun 19, 2019. The investigator was Mihaly S. Ligmond. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Belgium SA?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Catalent Belgium SA?
Mihaly S. Ligmond is named on this Form 483, for the inspection of Jun 11 – Jun 19, 2019. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Jun 11 – Jun 19, 2019, and the Form 483 is dated June 19, 2019.
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.