FDA Inspection 1198322 — Patheon Inc.

Patheon Inc. — FEI 3003516812

The FDA completed an inspection of Patheon Inc. on February 17, 2023 in Whitby. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Whitby (Canada)

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution