Catalent Belgium SA
Form 483 issued November 25, 2016 · Brussels, Belgium
- Inspection
- Nov 17 – Nov 25, 2016
- Investigators
- Ademola O. Daramola· Susanne M. Richardson
- Observations
- 2
- Pages
- 3
- FEI number
- 3007647000
In short: On November 25, 2016, FDA issued a Form 483 with 2 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Nov 17 – Nov 25, 2016. The investigators were Ademola O. Daramola and Susanne M. Richardson. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.42(c)(10)(v) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 2 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?
Ademola O. Daramola and Susanne M. Richardson are named on this Form 483, for the inspection of Nov 17 – Nov 25, 2016. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Nov 17 – Nov 25, 2016, and the Form 483 is dated November 25, 2016.
How do I get the full Form 483 for Catalent Belgium SA?
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