FDA Inspection 1261181 — Patheon Softgels B.V.

Patheon Softgels B.V. — FEI 1000384811

The FDA completed an inspection of Patheon Softgels B.V. on May 17, 2023 in Tilburg. 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
May 17, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tilburg (Netherlands)

Additional Details

Mutual Recognition Agreement (MRA)