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FDA Import Refusal OHL-0548682-8/1/1 — Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Limited — FEI 3004672766

The FDA refused shipment OHL-0548682-8/1/1 from Glenmark Pharmaceuticals Limited (India) on February 8, 2016. The refused product falls under Drugs and Biologics — NORGESTIMATE (PROGESTIN). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 8, 2016
Country
India
Product Category
Drugs and Biologics
Product Code
65JDA27 NORGESTIMATE (PROGESTIN)
Charges
75

Recent inspections

  • 1170118 (OAI Fri May 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082656 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885332 (NAI Fri May 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 849889 (VAI Fri Jul 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752519 (VAI Wed Oct 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-0861603-8/30002/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0490709-2/40002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0487274-2/90002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0615929-6/10002/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0679067-8/30002/1 (Mon Jun 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources