Catalent Ontario Limited
Form 483 issued June 29, 2018 · Windsor, Canada
- Inspection
- Jun 25 – Jun 29, 2018
- Investigator
- Sripal R. Mada
- Observations
- 2
- Pages
- 1
- FEI number
- 3000118564
In short: On June 29, 2018, FDA issued a Form 483 with 2 observations to Catalent Ontario Limited in Windsor, Ontario (FEI 3000118564) after an inspection that ran Jun 25 – Jun 29, 2018. The investigator was Sripal R. Mada.
What FDA observed
Preview: the opening words of each observation- 01
Failure to retain reserve samples for in vitro…
- 02
Documentation was not available to fully establish drug accountability for test and reference drug products utilized…
This inspection in context
Questions about this 483
What did FDA find at Catalent Ontario Limited?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Catalent Ontario Limited?
Sripal R. Mada is named on this Form 483, for the inspection of Jun 25 – Jun 29, 2018. Each investigator has a profile showing what they cite most.
When was Catalent Ontario Limited inspected by FDA?
The inspection ran Jun 25 – Jun 29, 2018, and the Form 483 is dated June 29, 2018.
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.