Catalent Belgium SA
Form 483 issued February 15, 2019 · Brussels, Belgium
- Inspection
- Feb 7 – Feb 15, 2019
- Investigators
- Jessica Hankins· Viviana Matta
- Observations
- 5
- Pages
- 4
- FEI number
- 3007647000
In short: On February 15, 2019, FDA issued a Form 483 with 5 observations to Catalent Belgium SA in Brussels, Belgium (FEI 3007647000) after an inspection that ran Feb 7 – Feb 15, 2019. The investigators were Jessica Hankins and Viviana Matta. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There shall be written procedures for production and process control designed to assure that the drug…
- 02
The responsibilities and procedures applicable to the quality control unit shall be in writing; such written…
- 03
Written production and process control procedures shall be followed in the execution of the various production…
- 04
Batch production and control records shall be prepared for each batch of drug product produced and…
This inspection in context
Jessica Hankins
1 document · 2019
Cites 211.100 (written procedures; deviations) 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 5 observations on this Form 483, mostly about production, quality system and packaging & labeling. 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?
Jessica Hankins and Viviana Matta are named on this Form 483, for the inspection of Feb 7 – Feb 15, 2019. Each investigator has a profile showing what they cite most.
When was Catalent Belgium SA inspected by FDA?
The inspection ran Feb 7 – Feb 15, 2019, and the Form 483 is dated February 15, 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.