FDA Inspection 1318922 — Zaklady Farmaceutyczne Polpharma S.A.

Zaklady Farmaceutyczne Polpharma S.A. — FEI 3002807920

The FDA completed an inspection of Zaklady Farmaceutyczne Polpharma S.A. on October 17, 2025 in Starogard Gdanski. 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 17, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Starogard Gdanski (Poland)

Additional Details

Mutual Recognition Agreement (MRA)