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FDA Import Refusal AR8-2020914-6/11/1C — Gopaldas Visram & Company Ltd.

Gopaldas Visram & Company Ltd. — FEI 3009565091

The FDA refused shipment AR8-2020914-6/11/1C from Gopaldas Visram & Company Ltd. (India) on October 22, 2021. The refused product falls under Drugs and Biologics — CYPROHEPTADINE HCL (ANTI-HISTAMINIC). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 22, 2021
Country
India
Product Category
Drugs and Biologics
Product Code
61XBL14 CYPROHEPTADINE HCL (ANTI-HISTAMINIC)
Charges
118,75

Recent inspections

  • 1259106 (VAI Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113868 (VAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034625 (VAI Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 8B4-0011542-2/200002/1C (Wed Mar 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6481231-4/61/1 (Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4850081-3/21/2 (Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 799-5285500-4/51/1 (Tue Oct 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AZE-0109546-7/11/1 (Tue Jul 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources