FDA Inspection 777640 — Alza Corporation

Alza Corporation — FEI 2938701

The FDA completed an inspection of Alza Corporation on April 12, 2012 in Vacaville, CA. 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
April 12, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Vacaville, CA (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented