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AstraZeneca UK Ltd — FDA Facility Profile

FEI 3002850317

AstraZeneca UK Ltd is an FDA-registered facility (FEI 3002850317) located in Macclesfield, GB. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Facility Details

Location
Macclesfield (GB)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1274179 (VAI Thu Apr 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1129231 (VAI Sun Feb 23 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017549 (NAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878183 (VAI Fri Apr 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 785250 (VAI Fri Mar 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 612417 (VAI Fri Aug 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • F23-9339962-1/80002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9340161-7/110002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8259678-2/11/1 (Thu Feb 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8NP-0055992-6/11/1 (Tue Feb 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-7385525-7/11/2 (Thu Dec 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-2547419-9/11/2 (Wed Jan 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8007252-1/11/1 (Mon Oct 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • FP1-0020719-9/351/1 (Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BUP-5004438-0/11/1 (Thu Nov 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8163104-2/11/1 (Wed Dec 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources