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FDA Import Refusal 523-1312474-6/11/4 — Sharon Bio-Medicine Ltd

Sharon Bio-Medicine Ltd — FEI 3004455093

The FDA refused shipment 523-1312474-6/11/4 from Sharon Bio-Medicine Ltd (India) on January 20, 2022. The refused product falls under Drugs and Biologics — KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC). Cited charge: 2280 This firm has 4 other import refusals on record.

Refusal Details

Date
January 20, 2022
Country
India
Product Category
Drugs and Biologics
Product Code
61WAS47 KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
Charges
2280

Recent inspections

  • 1267146 (VAI Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080156 (VAI Fri Feb 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 932049 (VAI Tue Jul 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 523-1312474-6/11/2 (Thu Jan 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 523-1312474-6/11/3 (Thu Jan 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 523-1312474-6/11/5 (Thu Jan 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 523-1312474-6/11/1 (Thu Jan 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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