According to the report of Japan's Sankei Shimbun, many links in the pharmaceutical process have been checked, but all failed. The drug involved was Itraconazole Tablets (T0EG08) produced by Kobayashi Chemical in June and July, 2020. 929 boxes of itraconazole tablets, about 100 tablets per box.
At that time, a person in charge supplemented the raw materials lost in the manufacturing process and misplaced the raw materials containing sleep inducers. According to the company's regulations, it takes two people to confirm when taking out the raw materials and weighing them, but only one person was working at that time.
In addition, in order to prevent human error, the use of bar codes for computer management has become commonplace in the industry, but the factories involved have not adopted it.
Before leaving the factory, the factory also needs to confirm the composition by liquid chromatography. However, according to Asahi Shimbun, a person familiar with the matter revealed that an unprecedented chromatographic peak appeared in the detection of this batch of finished products, which may be mixed with foreign materials. The field staff in charge of sample inspection noticed the change of inspection data and reported the situation to their boss, but no detailed internal investigation was conducted since then.
In July, the Ministry of Health, Labor and Welfare conducted a sampling inspection of each batch of products, but at that time, it was impossible to detect that sleeping pills were mixed with ingredients. Finally, the drug entered the market and was delivered to the medical institution on March/KLOC-0 in September and February. * * * 364 patients took the drug.
In February 2020, the illegal operation was exposed, and Kobayashi Hiroshi, president of Kobayashi Chemical Company, apologized to the public in February 2020. Feel responsible for making a big mistake? . The company said yes? Seriously? Treat the patient's death.
Since then, the Ministry of Health, Labor and Welfare has joined hands with independent administrative agencies? Comprehensive organization of drugs and medical devices? (PMDA) conducted an on-site inspection of Kobayashi Chemical according to the Law on Drugs and Medical Devices, and found that in addition to the products involved, the production process of some drugs was not approved by the Ministry of Health, Labor and Welfare.
Shortly after the on-site inspection, Kobayashi Chemical immediately announced the expansion of the recall. In addition to the three specifications of itraconazole tablets, antihypertensive drugs and other 15 prescription drugs will be recalled.
At that time, Kobayashi Chemical also said in the recall notice that the authorities' inspection report believed that these products needed to be re-tested. The company had re-tested and confirmed that there was no problem with any products and there was no serious risk to health, but in order to improve safety, it voluntarily recalled them.
This incident also triggered a knock-on effect in China. In recent years, Kobayashi Pharmaceutical, a Japanese company well versed in the China market, issued a statement saying that Kobayashi Chemical, a Japanese company involved in the case, has nothing to do with Kobayashi Pharmaceutical and its subsidiaries.
More than a month passed, and on February 9 this year, Fukui prefectural government imposed an administrative penalty on Kobayashi Chemical and ordered the company to suspend business for rectification 1 16 days. This is the longest punishment for Japanese pharmaceutical companies to be suspended for violating the Drug and Medical Device Law.
The TV station of Japan Broadcasting Association reported on the 9th that Kobayashi Chemical Company still has some problems, such as improper use of pharmaceutical raw materials, illegal pharmaceutical process, using yin-yang account books to cope with inspections, fabricating some quality inspection results, and still delivering goods after finding abnormalities? Eight big mistakes? .
Investigations by Fukui Prefecture and the Japanese Ministry of Health, Labor and Welfare found that Kobayashi Chemical Company fabricated some quality inspection results about 40 years ago. For example, about 80% of about 500 kinds of drugs produced by the company have false manufacturing records, and senior executives such as Kobayashi Hiroshi, the current president of the company, have long acquiesced in violations. At present, the company has voluntarily recalled 4 1 drug.