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Fukui Prefecture, Business Improvement Order Due to Mixing of Sleeping Pills
February 9, 2021 3:30 PM
Hiroyuki Kobayashi, Chairman of Kobayashi Kako Co., Ltd. (right) receives an order from Hiroyuki Kubota, Director of the Department of Health and Welfare, Fukui Prefecture = February 9, Fukui Prefectural Office
On February 9, Fukui prefecture suspended operations for 116 days based on the Pharmaceutical and Medical Devices Law due to the problem that components of sleep-inducing agents were mixed into therapeutic agents such as onychomycosis manufactured by Kobayashi Kako. in Awara City, Fukui Prefecture. I issued a business improvement order. 116 days will be the longest administrative punishment for pharmaceutical manufacturers.
According to the prefecture, there are many related laws and regulations, such as the existence of procedure manuals that differ from the national approval content for multiple products containing this drug, the creation of false “double books” records for on-site inspections, and the Manufacture of quality test results Rape was confirmed to have been committed over many years.
On the same day at the prefectural office, Hiroyuki Kubota, director of the prefectural health and welfare department, delivered an order to President Hiroyuki Kobayashi, saying, “116 days is not a short period, but I hope the entire company will do whatever is within their power. Everything possible to revitalize it. “He declared. After receiving it, President Kobayashi said in an interview with the press:” We sincerely apologize to the victims who have suffered serious damage to health. We deeply apologize for the inconvenience caused to the citizens of Fukui Prefecture. I bowed deeply.
Part of the oral antifungal agent itraconazole tablet 50 “MEEK” was contaminated. The prefectural government carries out raw material extraction works that must be carried out by two people due to lack of personnel ▽ There is an unapproved manual of procedures ▽ Addition of raw materials not approved by the government ▽ Creation of false records ▽ Partial test Se concluded that real conditions such as the fact that the test results were not implemented and the test results were falsified. These scams have also been confirmed in other products.
Certified “manufacturing and management managers have tolerated” manufacturing and double books that deviate from the approved method. As a background, the head of the pharmaceutical business did not adequately supervise the company, and the quality control department did not adequately confirm with the manufacturing department. “The biggest problem is that management violates these laws and regulations. I knew it, but did not take any improvement measures.”
The business improvement order required compliance with laws and regulations, education of officers and employees, and a review of the business system related to manufacturing and sales. The time to resume business will be reviewed based on the content of the business improvement plan to be presented in the future, and “shipping cannot be resumed until business improvement is complete.”
According to Kobayashi Kako, as of day 8, 239 people who took the mixed tablets reported health problems such as impaired consciousness, and two women in their 70s and men in their 80s died.
Kobayashi Kako was established in 1961. It employs about 800 people and has pharmaceutical sales of 37 billion yen (fiscal year 2019).
The longest suspension of operations for pharmaceutical manufacturers so far was 110 days received from the Ministry of Health, Labor and Welfare by the Institute of Chemistry and Serum Therapy (Kaketsuken) in Kumamoto City, Kumamoto Prefecture in 2016 .
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