FDA Inspection 1322022 — Opocrin SPA

Opocrin SPA — FEI 3009116141

The FDA completed an inspection of Opocrin SPA on October 30, 2025 in Nonantola. 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 30, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nonantola (Italy)

Additional Details

Mutual Recognition Agreement (MRA)