FDA Inspection 1313064 — Esteve Quimica, S.A.

Esteve Quimica, S.A. — FEI 3002806937

The FDA completed an inspection of Esteve Quimica, S.A. on September 18, 2025 in Celra. 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
September 18, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Celra (Spain)

Additional Details

Mutual Recognition Agreement (MRA)