FDA Inspection 601486 — Corden Pharma S.p.A.

Corden Pharma S.p.A. — FEI 3002880938

The FDA completed an inspection of Corden Pharma S.p.A. on July 16, 2009 in Caponago. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Caponago (Italy)

Citations

IDCFRDescription
188521 CFR 211.165(b)Microbiological testing