To the people concerned, the company created test records without conducting some quality tests due to the problem that the components of the sleep-inducing agent were mixed in the therapeutic drugs such as athlete's foot manufactured by the pharmaceutical manufacturer in Fukui Prefecture. I found out from the interview.

Fukui Prefecture plans to issue a business suspension order for more than 110 days, the longest ever, in early next month.

Kobayashi Kako, a pharmaceutical manufacturer in Awara City, Fukui Prefecture, manufactures and sells a therapeutic drug for athlete's foot and other mycoses that contains a sleep-inducing agent. Damage has been reported.



The prefecture and the Ministry of Health, Labor and Welfare jointly conducted an on-site inspection last month to investigate the actual state of quality control, but according to the people concerned, the company created test records without conducting some quality tests. Is confirmed.



In addition, the work that should be done by two people in the process of adding raw materials was left to one person, and the person in charge also visually checked, so the container of the main component and the container containing the sleep inducer that were stored in the same room It was concluded that the mistake was the cause of the contamination.



Furthermore, even if an abnormality is found in the pre-shipment quality inspection, it is shipped without investigating the cause, and it was approved in the past prefecture survey to hide the fact that the procedure manual of the manufacturing process that has not been approved by the government was used. It means that he was presenting the procedure manual.



For this reason, Fukui Prefecture has decided to issue an order to suspend operations for more than 110 days, which is the longest in history, after consulting with the Ministry of Health, Labor and Welfare, saying that quality control standards were not observed.



Fukui Prefecture has already informed the company of its disposal policy, and plans to officially dispose of it early next month.