Juno Pharma Canada Inc.
Form 483 issued January 17, 2024 · Montreal, Canada
- Inspection
- Jan 9 – Jan 17, 2024
- Investigator
- Edmund F. Mrak
- Observations
- 2
- Pages
- 3
- FEI number
- 3004153143
In short: On January 17, 2024, FDA issued a Form 483 with 2 observations to Juno Pharma Canada Inc. in Montreal, Quebec (FEI 3004153143) after an inspection that ran Jan 9 – Jan 17, 2024. The investigator was Edmund F. Mrak. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×) · 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmJuno Pharma Canada Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Juno Pharma Canada Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Juno Pharma Canada Inc.?
Edmund F. Mrak is named on this Form 483, for the inspection of Jan 9 – Jan 17, 2024. Each investigator has a profile showing what they cite most.
When was Juno Pharma Canada Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 17, 2024, and the Form 483 is dated January 17, 2024.
How do I get the full Form 483 for Juno Pharma Canada Inc.?
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