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Hetero Labs Limited — FDA Facility Profile

FEI 3005406526

Hetero Labs Limited is an FDA-registered facility (FEI 3005406526) located in Telangana 500055, IN. Registered operations: MANUFACTURE. RegDataLab tracks 8 FDA inspections at this facility.

Facility Details

Location
Telangana 500055 (IN)
Registration Expires
December 31, 2026
Operations
MANUFACTURE
Source
decrs

Recent inspections

  • 1210507 (VAI Fri Jul 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092347 (VAI Fri Jun 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045339 (NAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993030 (VAI Wed Oct 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940470 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852628 (VAI Fri Oct 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 758949 (VAI Thu Dec 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 631904 (VAI Mon Nov 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 1FX-8099523-5/30002/3 (Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5115689-5/20003/1 (Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5115689-5/10003/1 (Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7842487-3/11/1 (Mon Sep 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8162362-7/11/1 (Wed Dec 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6743853-7/1/1 (Wed Aug 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • UPS-4341049-9/1/1 (Mon Mar 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources