FDA Inspection 1277006 — Lab Ofichem B.V.

Lab Ofichem B.V. — FEI 1000286391

The FDA completed an inspection of Lab Ofichem B.V. on October 12, 2023 in Ter Apel. 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
October 12, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ter Apel (Netherlands)

Additional Details

Mutual Recognition Agreement (MRA)