FDA Inspection 710425 — Helsinn Birex Pharmaceuticals Ltd.

Helsinn Birex Pharmaceuticals Ltd. — FEI 3003724414

The FDA completed an inspection of Helsinn Birex Pharmaceuticals Ltd. on May 27, 2010 in Mulhuddart. 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
May 27, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mulhuddart (Ireland)