FDA Inspection 1135978 — PMC Isochem

PMC Isochem — FEI 3002807312

The FDA completed an inspection of PMC Isochem on March 6, 2020 in Gennevilliers. 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 6, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gennevilliers (France)

Additional Details

Mutual Recognition Agreement (MRA)