Contract Pharmaceuticals Limited Canada
Form 483 issued November 3, 2023 · Mississauga, Canada
- Inspection
- Oct 30 – Nov 3, 2023
- Investigator
- Kristina L. Conroy
- Observations
- 1
- Pages
- 1
- FEI number
- 3001581899
In short: On November 3, 2023, FDA issued a Form 483 with 1 observation to Contract Pharmaceuticals Limited Canada in Mississauga, Canada (FEI 3001581899) after an inspection that ran Oct 30 – Nov 3, 2023. The investigator was Kristina L. Conroy. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
This inspection in context
Kristina L. Conroy
10 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmContract Pharmaceuticals Limited Canada history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Contract Pharmaceuticals Limited Canada?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Contract Pharmaceuticals Limited Canada?
Kristina L. Conroy is named on this Form 483, for the inspection of Oct 30 – Nov 3, 2023. Each investigator has a profile showing what they cite most.
When was Contract Pharmaceuticals Limited Canada inspected by FDA?
The inspection ran Oct 30 – Nov 3, 2023, and the Form 483 is dated November 3, 2023.
How do I get the full Form 483 for Contract Pharmaceuticals Limited Canada?
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.