Home / Import refusals / SCS-8566337-0/10002/1

FDA Import Refusal SCS-8566337-0/10002/1 — Hetero Labs Ltd

Hetero Labs Ltd — FEI 3007785633

The FDA refused shipment SCS-8566337-0/10002/1 from Hetero Labs Ltd (India) on October 22, 2025. The refused product falls under Drugs and Biologics — MIRABEGRON (ADRENERGIC). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 22, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
60CCA61 MIRABEGRON (ADRENERGIC)
Charges
118

Recent inspections

  • 1120998 (NAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-9410963-2/40002/1 (Mon Mar 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9426366-0/70003/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-9272027-0/10003/1 (Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7261494-2/23/1 (Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1574899-7/11/1 (Fri Aug 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources