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[Yakuji Nippo]Business Suspension Order to Kobayashi Kako Co., Ltd for 116 Days - Longest Ever, For Keeping Quiet about Manufacturing Conditions

Data Fabrication and Dual Bookkeeping as Well
Regarding the case of the health damage that occurred due to a sleep-inducing...
  • Target market
    Japan
  • Business category
    Pharmaceutical, Biopharmaceutical, Regerative medicine, Medical device, Digital health, Others
  • Business function
    Marketing >
  • Keyword
  • Author
    "LSMIP Editorial Office" of "CM Plus Corporation"
  • Availability
    Membership

Detail


株式会社薬事日報社から許諾を受けて、株式会社シーエムプラスが英語に翻訳しております。
オリジナルの正式言語は日本語であり、内容および解釈については日本語が優先されます。
With permission from Yakuji Nippo, Limited, CM Plus Corporation translated into English.
The original article is authored in Japanese, and the Japanese shall prevail in meaning in terms of content and interpretation.

 

Fukui Prefecture
Business Suspension Order to Kobayashi Kako Co., Ltd for 116 Days - Longest Ever, For Keeping Quiet about Manufacturing Conditions

February 12th 2021

Data Fabrication and Dual Bookkeeping as Well

Regarding the case of the health damage that occurred due to a sleep-inducing agent getting mixed in with the antifungal agent "ITRACONAZOLE Tablets" which Kobayashi Kako Co., Ltd has manufactured and sold, Fukui Prefecture, on the 9th, ordered the company to suspend its business for 116 days, the longest ever, based on the Pharmaceutical and Medical Device Act (PMD Act). They have imposed a strict punishment after seriously since while the management had been fully aware of the manufacturing conditions such as manufacturing according to a procedure manual that is different from an authorized document, creating a dual bookkeeping for on-site inspection, and fabricating quality test results, it has kept quiet about them for a long time.

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For this translated article in English, CM Plus Corporation shall have the copyright.
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Copyright © 2021 LSMIP office / CM Plus Singapore Pte. Ltd.

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