E-Z-EM Canada Inc.
Form 483 issued October 20, 2023 · Anjou, Canada
- Inspection
- Oct 16 – Oct 20, 2023
- Investigator
- Jose M. Cayuela
- Observations
- 2
- Pages
- 2
- FEI number
- 3002808342
In short: On October 20, 2023, FDA issued a Form 483 with 2 observations to E-Z-EM Canada Inc. in Anjou, Quebec (FEI 3002808342) after an inspection that ran Oct 16 – Oct 20, 2023. The investigator was Jose M. Cayuela. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmE-Z-EM Canada Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at E-Z-EM Canada Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected E-Z-EM Canada Inc.?
Jose M. Cayuela is named on this Form 483, for the inspection of Oct 16 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was E-Z-EM Canada Inc. inspected by FDA?
The inspection ran Oct 16 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
How do I get the full Form 483 for E-Z-EM Canada Inc.?
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