Catalent Ontario Limited
Form 483 issued January 20, 2023 · Windsor, Canada
- Inspection
- Jan 16 – Jan 20, 2023
- Observations
- 1
- Pages
- 1
- FEI number
- 3000118564
In short: On January 20, 2023, FDA issued a Form 483 with 1 observation to Catalent Ontario Limited in Windsor, Ontario (FEI 3000118564) after an inspection that ran Jan 16 – Jan 20, 2023. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.170(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product reserve samples are not stored in an immediate container-closure system that has essentially the…
This inspection in context
Questions about this 483
What did FDA find at Catalent Ontario Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
When was Catalent Ontario Limited inspected by FDA?
The inspection ran Jan 16 – Jan 20, 2023, and the Form 483 is dated January 20, 2023.
How do I get the full Form 483 for Catalent Ontario Limited?
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.