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Zydus Lifesciences Limited — FDA Facility Profile

FEI 3002984011

Zydus Lifesciences Limited is an FDA-registered facility (FEI 3002984011) located in Gujarat 382210, IN. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 10 or more FDA inspections and 3 compliance actions at this facility.

Facility Details

Location
Gujarat 382210 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Recent inspections

  • 1177670 (VAI Fri Aug 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088772 (OAI Fri May 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090231 (NAI Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047493 (NAI Fri Feb 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006533 (NAI Thu Feb 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895756 (OAI Fri Sep 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850780 (VAI Mon Aug 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 772764 (VAI Thu Feb 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709477 (OAI Thu Feb 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 575706 (NAI Fri Feb 06 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-1876875-2/11/1 (Thu Nov 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-9125691-8/11/1 (Wed Mar 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6460128-5/1/4 (Fri Aug 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6460128-5/1/3 (Fri Aug 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6464383-2/1/1 (Wed Jul 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2109334-6/1/1A (Tue May 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-8102942-6/1/1 (Wed Aug 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-8102942-6/1/2 (Wed Aug 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-6038873-3/1/1 (Thu Apr 26 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-6038873-3/1/2 (Thu Apr 26 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources