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FDA Import Refusal 112-6636538-1/1/1B — Bio Focus Co. Ltd.

Bio Focus Co. Ltd. — FEI 3005841978

The FDA refused shipment 112-6636538-1/1/1B from Bio Focus Co. Ltd. (South Korea) on April 23, 2012. The refused product falls under Devices — ANTIGENS, NONTREPONEMAL, ALL. Cited charges: 118,341,508 This firm has 2 other import refusals on record.

Refusal Details

Date
April 23, 2012
Country
South Korea
Product Category
Devices
Product Code
83GMQ ANTIGENS, NONTREPONEMAL, ALL
Charges
118,341,508

Recent inspections

  • 918396 (VAI Thu Feb 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836155 (OAI Wed Apr 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 112-6636538-1/1/1A (Mon Apr 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-6636538-1/1/1C (Mon Apr 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources