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Hetero Labs Limited — FDA Facility Profile

FEI 3008294355

Hetero Labs Limited is an FDA-registered facility (FEI 3008294355) located in Telangana 509301, IN. Registered operations: MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

Facility Details

Location
Telangana 509301 (IN)
Registration Expires
December 31, 2026
Operations
MANUFACTURE
Source
decrs

Recent inspections

  • 1218220 (VAI Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999209 (OAI Tue Nov 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833134 (VAI Thu May 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-7671930-9/10003/1 (Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5429250-3/11/1 (Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3949418-2/11/1 (Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5821380-9/11/1 (Wed Apr 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources