FDA Inspection 1083696 — Apotex Fermentation Inc.

Apotex Fermentation Inc. — FEI 3000043315

The FDA completed an inspection of Apotex Fermentation Inc. on March 22, 2019 in Winnipeg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 22, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Winnipeg (Canada)