FDA Inspection 1227777 — Juno Pharma Canada Inc.

Juno Pharma Canada Inc. — FEI 3004153143

The FDA completed an inspection of Juno Pharma Canada Inc. on January 17, 2024 in Montreal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Montreal (Canada)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance