FDA Inspection 1092538 — Opocrin SPA

Opocrin SPA — FEI 3002807810

The FDA completed an inspection of Opocrin SPA on September 29, 2017 in Formigine. 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 29, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Formigine (Italy)

Additional Details

Mutual Recognition Agreement (MRA)