FDA Inspection 1115572 — AstraZeneca AB

AstraZeneca AB — FEI 3003342394

The FDA completed an inspection of AstraZeneca AB on December 7, 2017 in Sodertalje. 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
December 7, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sodertalje (Sweden)

Additional Details

Mutual Recognition Agreement (MRA)