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FDA Import Refusal 314-0218386-2/12/1 — Kyowa Hakko Bio Co., Ltd.

Kyowa Hakko Bio Co., Ltd. — FEI 3002807424

The FDA refused shipment 314-0218386-2/12/1 from Kyowa Hakko Bio Co., Ltd. (Japan) on August 20, 2018. The refused product falls under Drugs and Biologics — MISCELLANEOUS PATENT MEDICINES, ETC.. Cited charges: 118,16,3280,75 This firm has 2 other import refusals on record.

Refusal Details

Date
August 20, 2018
Country
Japan
Product Category
Drugs and Biologics
Product Code
66VAR99 MISCELLANEOUS PATENT MEDICINES, ETC.
Charges
118,16,3280,75

Recent inspections

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  • 1031649 (OAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873726 (NAI Thu Mar 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 314-0218105-6/12/1 (Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 510-8208044-4/11/1 (Thu Jul 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)

FDA data resources