FDA Inspection 1074411 — Sofina Foods Inc.

Sofina Foods Inc. — FEI 3008630334

The FDA completed an inspection of Sofina Foods Inc. on December 14, 2018 in Burlington. 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
December 14, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Burlington (Canada)

Citations

IDCFRDescription
900121 CFR 211.22(a)Lack of quality control unit