Toyama Prefecture has told Kitanihon Pharmaceutical, a pharmaceutical company located in Kamiichi, that there were serious problems in manufacturing and quality control, such as manufacturing pharmaceuticals using additives not listed in the national and prefectural approval documents. On the 14th, we issued a business suspension order and a business improvement order.
According to Toyama Prefecture, the pharmaceutical company "Kitanihon Pharmaceutical" in Kamiichi uses additives in amounts different from the national and prefectural approvals for seven items of Chinese herbal medicines such as obesity medicines, or states them in the approvals. In addition to manufacturing using no additives, we did not take appropriate measures such as collecting products that did not conform to the standards in post-shipment tests.
Toyama Prefecture announced that it has issued an order to suspend operations based on the Pharmaceutical and Medical Devices Act on the 14th, saying that there was a serious problem in the manufacturing and quality control of "Kitanihon Pharmaceutical".
The period starts from 16 days, and production will be suspended for 26 days and production and sales will be suspended for 28 days.
It also requires the company to issue a business improvement order to investigate the cause of the violation and submit an improvement plan within one month.
The problem this time is that an inspection conducted by the prefecture in June without notice revealed a violation of one item, and the prefecture continued to investigate.
According to the company, violations have been committed for some items since at least around 2004, and a total of about 110,000 items have already begun to be voluntarily recalled.
No health hazards have been reported so far.
Kitanihon Pharmaceutical commented, "We deeply regret and apologize for the lack of an organizational structure for legal compliance. In the future, we will do our utmost to prevent this from happening again."