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AstraZeneca AB — FDA Facility Profile

FEI 3002806411

AstraZeneca AB is an FDA-registered facility (FEI 3002806411) located in Sodertalje, SE. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; RELABEL. RegDataLab tracks 9 FDA inspections at this facility.

Facility Details

Location
Sodertalje (SE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; RELABEL
Source
decrs

Recent inspections

  • 1327052 (VAI Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1248349 (VAI Thu Dec 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124752 (VAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102604 (VAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010067 (VAI Tue Feb 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897789 (NAI Fri Sep 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853188 (NAI Tue May 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 724676 (NAI Thu Dec 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 654557 (NAI Fri Mar 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-7960283-3/10003/1 (Fri Dec 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9054909-6/10002/1 (Thu Dec 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7697916-8/20002/1 (Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8128237-6/31/1 (Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6439524-5/11/1 (Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5476126-5/21/1 (Mon Aug 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1469564-7/31/1 (Thu Mar 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7154204-4/41/1 (Fri May 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • FP1-0021113-4/221/1 (Fri Mar 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 655-1859208-8/6/1 (Mon Feb 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources