Home / Import refusals / AEK-6302975-2/11/1

FDA Import Refusal AEK-6302975-2/11/1 — Biocon Limited

Biocon Limited — FEI 1000172912

The FDA refused shipment AEK-6302975-2/11/1 from Biocon Limited (India) on September 18, 2019. The refused product falls under Drugs and Biologics — SIROLIMUS (IMMUNOSUPPRESSIVE). Cited charge: 75 This firm has 4 other import refusals on record.

Refusal Details

Date
September 18, 2019
Country
India
Product Category
Drugs and Biologics
Product Code
64TAA12 SIROLIMUS (IMMUNOSUPPRESSIVE)
Charges
75

Recent inspections

  • 1250808 (VAI Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120320 (VAI Wed Feb 26 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1070344 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044697 (VAI Fri Mar 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985592 (VAI Fri Aug 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-7231643-1/112/1 (Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 506-0814126-8/1/1 (Thu Jul 27 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-5097089-4/1/1 (Thu Jan 06 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 595-0501717-4/1/1 (Thu Apr 08 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources