FDA Inspection 895233 — AstraZeneca Pharmaceuticals, LP

AstraZeneca Pharmaceuticals, LP — FEI 2517100

The FDA completed an inspection of AstraZeneca Pharmaceuticals, LP on August 27, 2014 in Newark, DE. 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
August 27, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Newark, DE (United States)

Citations

IDCFRDescription
430321 CFR 211.67(b)Written procedures fail to include