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Novartis Manufacturing NV — FDA Facility Profile

FEI 3002037047

Novartis Manufacturing NV is an FDA-registered facility (FEI 3002037047) located in Puurs-Sint-Amands Antwerpen, BE. Registered operations: LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Facility Details

Location
Puurs-Sint-Amands Antwerpen (BE)
Registration Expires
December 31, 2026
Operations
LABEL; MANUFACTURE; PACK
Source
both

Recent inspections

  • 1305248 (VAI Wed Mar 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152317 (VAI Thu Apr 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1126883 (VAI Fri Nov 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 997972 (VAI Tue Nov 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874952 (NAI Wed Mar 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 645897 (NAI Fri Jan 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-5763396-6/11/1 (Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6480757-9/21/1 (Tue Oct 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-2074595-0/11/1 (Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0794946-5/11/1 (Tue Aug 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1379770-7/31/1 (Wed Jul 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8T9-0026977-6/11/1 (Fri Dec 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5361810-4/11/1 (Wed Nov 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-1084235-9/11/1 (Fri Feb 05 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8624684-7/11/1 (Tue Jan 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8332487-0/11/1 (Fri Aug 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources