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Alkem Laboratories Limited — FDA Facility Profile

FEI 3006370533

Alkem Laboratories Limited is an FDA-registered facility (FEI 3006370533) located in Himachal Pradesh 173205, IN. Registered operations: ANALYSIS; MANUFACTURE; PACK; REPACK. RegDataLab tracks 9 FDA inspections at this facility.

Facility Details

Location
Himachal Pradesh 173205 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE; PACK; REPACK
Source
decrs

Recent inspections

  • 1233569 (VAI Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118336 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1140381 (VAI Tue Nov 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089865 (VAI Fri May 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007598 (VAI Fri Mar 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939486 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853251 (NAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802325 (NAI Fri Aug 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 634479 (VAI Fri Nov 06 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-5624433-0/11/4 (Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5822275-1/21/1 (Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7626844-0/41/1 (Mon Mar 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7725460-5/21/1 (Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6370359-9/31/4 (Wed Dec 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1745728-4/11/1 (Mon Apr 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1879171-7/11/10 (Wed Sep 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6349241-4/21/1 (Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-3549397-3/11/1 (Wed May 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-3549397-3/11/2 (Wed May 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources