Catalent Belgium SA
Form 483 issued August 19, 2022 · Brussels, Belgium
- Inspection
- Aug 10 – Aug 19, 2022
- Investigator
- Yasamin Ameri
- Observations
- 9
- Pages
- 10
- FEI number
- 3007647000
In short: On August 19, 2022, FDA issued a Form 483 with 9 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Aug 10 – Aug 19, 2022. The investigator was Yasamin Ameri. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.113 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high -efficiency paiiiculate air…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
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 facilities & equipment, production and quality system. 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?
Yasamin Ameri is named on this Form 483, for the inspection of Aug 10 – Aug 19, 2022. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Aug 10 – Aug 19, 2022, and the Form 483 is dated August 19, 2022.
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.