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Japanese authorities recently conducted an inspection of the beni-koji red yeast rice factory operated by Kobayashi Pharmaceutical in Kinokawa City, Wakayama Prefecture. The inspection comes after reports of deaths and hospitalizations of individuals who have used this product. It was discovered that the factory in Wakayama had taken over production equipment from the Osaka factory, which had ceased operations in December due to outdated machinery. Additionally, Kobayashi Pharmaceutical shipped additional ingredients to the Wakayama factory in January and beyond.

The company leaders have pledged to cooperate with authorities to determine the cause of the issues promptly. Local media reported that puberulic acid, a natural compound derived from green mold produced during rice fermentation, may have been the cause of the adverse reactions. This acid is toxic and is not permitted in functional foods. The beni-koji production line did not meet Good Manufacturing Practices (GMP) certification standards.

On February 31, Japanese Ministry of Health officials visited the factory for inspection, and the National Institute of Health Sciences will be conducting further analyses to understand the toxicity of the acid and its connection to the health problems reported. During a press conference on March 29, President and CEO Akihiro Kobayashi expressed apologies for the issues faced by users of the product and vowed to identify the cause and take appropriate actions. The company’s products are also distributed in several other Asian countries, with sales suspended in China and Taiwan. As of March 27, Japan has reported five deaths and over 115 illnesses linked to the beni-koji product, prompting detailed investigations into the manufacturing process and its effects on health.

Furthermore, Vietnam’s Food Safety Department has confirmed that beni-koji products have not been authorized for circulation in their country, warning people against purchasing them through unofficial channels like social media. The department urged people to report any sightings of these products for proper legal handling as business operations at Kobayashi Pharmaceutical continue under scrutiny with further action being taken to address

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