FDA Inspection 1248349 — AstraZeneca AB

AstraZeneca AB — FEI 3002806411

The FDA completed an inspection of AstraZeneca AB on December 1, 2022 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 1, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sodertalje (Sweden)

Additional Details

Mutual Recognition Agreement (MRA)