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FDA Import Refusal AEK-7151964-5/1/2 — Windlas Healthcare Private Limited

Windlas Healthcare Private Limited — FEI 3005339091

The FDA refused shipment AEK-7151964-5/1/2 from Windlas Healthcare Private Limited (India) on January 5, 2007. The refused product falls under Drugs and Biologics — OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC). Cited charge: 75 This firm has 4 other import refusals on record.

Refusal Details

Date
January 5, 2007
Country
India
Product Category
Drugs and Biologics
Product Code
61GDK85 OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
Charges
75

Recent inspections

  • 1101210 (OAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055378 (VAI Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 962641 (NAI Wed Feb 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882841 (VAI Fri Jun 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-3142994-8/21/2 (Thu Feb 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0801351-6/41/1 (Fri Mar 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9278493-0/21/1 (Fri Jun 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7151964-5/1/1 (Fri Jan 05 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources