Home / Import refusals / 1FX-8099523-5/30002/3

FDA Import Refusal 1FX-8099523-5/30002/3 — Hetero Labs Limited - Unit III

Hetero Labs Limited - Unit III — FEI 3005406526

The FDA refused shipment 1FX-8099523-5/30002/3 from Hetero Labs Limited - Unit III (India) on May 15, 2026. The refused product falls under Drugs and Biologics — DAPAGLIFLOZIN (ANTI-DIABETIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 15, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61PCA70 DAPAGLIFLOZIN (ANTI-DIABETIC)
Charges
75

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))

Other import refusals

  • 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)

FDA data resources