Sun Pharma Canada Inc.
Form 483 issued September 16, 2022 · Brampton, Canada
- Inspection
- Sep 12 – Sep 16, 2022
- Investigator
- Marian E. Ramirez
- Observations
- 2
- Pages
- 3
- FEI number
- 3002808384
In short: On September 16, 2022, FDA issued a Form 483 with 2 observations to Sun Pharma Canada Inc. in Brampton, Ontario (FEI 3002808384) after an inspection that ran Sep 12 – Sep 16, 2022. The investigator was Marian E. Ramirez. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.110(a) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted…
- 02
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Marian E. Ramirez
20 documents · 2016–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSun Pharma Canada Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Pharma Canada Inc.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Sun Pharma Canada Inc.?
Marian E. Ramirez is named on this Form 483, for the inspection of Sep 12 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Sun Pharma Canada Inc. inspected by FDA?
The inspection ran Sep 12 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
How do I get the full Form 483 for Sun Pharma Canada Inc.?
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.