FDA Inspection 1007326 — Pfizer Ireland Pharmaceuticals Unlimited Company

Pfizer Ireland Pharmaceuticals Unlimited Company — FEI 3004145594

The FDA completed an inspection of Pfizer Ireland Pharmaceuticals Unlimited Company on March 10, 2017 in Dublin 22. 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
March 10, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dublin 22 (Ireland)

Citations

IDCFRDescription
360221 CFR 211.160(a)Deviations from laboratory control requirements