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FDA Import Refusal 97X-0045017-0/11/2 — Biocon Biologics Limited

Biocon Biologics Limited — FEI 3003981475

The FDA refused shipment 97X-0045017-0/11/2 from Biocon Biologics Limited (India) on September 17, 2021. The refused product falls under Drugs and Biologics — ETANERCEPT. Cited charge: 179 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 17, 2021
Country
India
Product Category
Drugs and Biologics
Product Code
61YIA03 ETANERCEPT
Charges
179

Recent inspections

  • 1245708 (VAI Fri Jul 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100840 (VAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050980 (VAI Tue May 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016114 (VAI Sat Jun 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948968 (VAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • B4S-0008135-4/11/3 (Fri Jun 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1762084-2/11/1 (Fri Sep 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1701243-3/6/1 (Tue Jan 05 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5692501-4/1/1 (Fri Sep 05 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-9154522-9/1/1 (Thu Oct 22 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources