FDA Inspection 1244013 — Sintetica S.A.

Sintetica S.A. — FEI 3004058163

The FDA completed an inspection of Sintetica S.A. on November 9, 2023 in Mendrisio. 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
November 9, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mendrisio (Switzerland)

Additional Details

Mutual Recognition Agreement (MRA)