Catalent Belgium SA
Form 483 issued October 26, 2021 · Brussels, Belgium
- Inspection
- Oct 18 – Oct 26, 2021
- Investigators
- Lindsey Brown· Wayne Seifert
- Observations
- 7
- Pages
- 6
- FEI number
- 3007647000
In short: On October 26, 2021, FDA issued a Form 483 with 7 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Oct 18 – Oct 26, 2021. The investigators were Lindsey Brown and Wayne Seifert. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.100 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its…
- 02
Failure to establish written procedures for production and process control designed to assure that the drug…
- 03
Validations, designed to prevent microbial contamination of the drug product purporting to be sterile, have…
- 04
A written procedure designed to prevent contamination of products during aseptic…
This inspection in context
Lindsey Brown
4 documents · 2017–2024
Cites 211.160 (general requirements) 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 211.100
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 facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Catalent Belgium SA?
Lindsey Brown and Wayne Seifert are named on this Form 483, for the inspection of Oct 18 – Oct 26, 2021. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Oct 18 – Oct 26, 2021, and the Form 483 is dated October 26, 2021.
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.