FDA Inspection 1144006 — Roquette Freres

Roquette Freres — FEI 1000114558

The FDA completed an inspection of Roquette Freres on December 4, 2020 in Lestrem. 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
December 4, 2020
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lestrem (France)

Additional Details

Mutual Recognition Agreement (MRA)