FDA Inspection 906518 — Rosemont Pharmaceuticals Ltd.

Rosemont Pharmaceuticals Ltd. — FEI 3002442738

The FDA completed an inspection of Rosemont Pharmaceuticals Ltd. on December 12, 2014 in Leeds. 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
December 12, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Leeds (United Kingdom)

Citations

IDCFRDescription
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.