Catalent Belgium SA
Form 483 issued July 31, 2018 · Brussels, Belgium
- Inspection
- Jul 23 – Jul 31, 2018
- Investigators
- James W. Whitney· Lisa B. Orr· Youmin Wang
- Observations
- 4
- Pages
- 2
- FEI number
- 3007647000
In short: On July 31, 2018, FDA issued a Form 483 with 4 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Jul 23 – Jul 31, 2018. The investigators were James W. Whitney, Lisa B. Orr and Youmin Wang. 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The accuracy and reproducibility of test methods…
This inspection in context
James W. Whitney
3 documents · 2017–2018
Cites 820.30(g) (design controls) 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 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Catalent Belgium SA?
James W. Whitney, Lisa B. Orr and Youmin Wang are named on this Form 483, for the inspection of Jul 23 – Jul 31, 2018. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Jul 23 – Jul 31, 2018, and the Form 483 is dated July 31, 2018.
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.