Business Improvement Order Records in Japan

On September 9, 2022, a charter bus operator involved in a travel using a chartered bus was subject to administrative disposition for violating Article 10 of the Road Transport Act, as the operator received a commission that undercut safety costs when accepting transportation, and this commission was paid to the travel agency.

It was confirmed that Medtronic Japan Co., Ltd. did not report adverse event cases related to their medical device (Insulin Pump Injection Set), which are subject to reporting obligations for foreign medical devices, within the specified deadline.

On the trip on November 7, 2020, the charter bus operator was subject to administrative disposition for violating Article 10 of the Road Transport Act due to the interference of brokerage fees in the transportation of the charter bus, which prevented the operator from collecting the fare and charges they should have received and hindered expenses necessary for safety. The travel agency involved in the transaction was also implicated.

On July 26, 2024, the Ministry of Economy, Trade and Industry issued a business improvement order to Chubu Electric Mirai Co., Ltd. under the Gas Business Act, based on Article 20, Paragraph 1, to ensure proper gas transactions.

The Ministry of Economy, Trade and Industry issued an order for business improvement to Toho Gas Co., Ltd. and Chubu Electric Mirai Co., Ltd. under the Gas Business Act on July 23, 2024, following an opinion hearing by the Electricity and Gas Trading Monitoring Committee.

On July 23, 2024, the Ministry of Economy, Trade and Industry issued an order for business improvement to Chubu Electric Mirai Corporation under the Gas Business Act, following a consultation with the Electricity and Gas Trading Surveillance Commission.

The Ministry of Economy, Trade and Industry issued a business improvement order to Toho Gas Co., Ltd. on July 5, 2024, under the Gas Business Act, due to multiple instances of frequent information exchanges between senior staff and Chuden Mirai, which involved confirming order intentions and bid prices.

The Ministry of Economy, Trade and Industry issued a business improvement order to Chubu Electric Mirai Corporation under the Gas Business Act on July 5, 2024, due to multiple instances of frequent information exchanges with Toho Gas over a long period, including sharing of bid prices and determining prospective order recipients.

A chartered bus operator involved in a trip using a chartered bus on November 19-20, 2020, was administratively penalized for violating Article 10 of the Road Transport Law by accepting a transaction fee that undercut safety costs and was paid to the travel agency.

On the trip arranged with a chartered bus on August 23, 2021, it was confirmed that the transaction fees affected the collection of fares and charges that the charter bus operator should have received, hindering expenses necessary for safety measures and impacting the safety of the trip.

Sawai Pharmaceutical Co., Ltd. Kyushu Factory conducted quality tests on the pharmaceutical product Tepelonen Capsules 50mg 'Sawai' using a testing method different from that approved (replacing the drug into a different capsule before performing dissolution testing).

The Ministry of Economy, Trade and Industry issued a business improvement order to Kyushu Electric Power Co., Inc. on July 14, 2023, based on Article 2-17-1 of the Electric Business Act.

The Ministry of Economy, Trade and Industry issued a business improvement order to Chugoku Electric Power Co., Inc. on July 14, 2023, based on Article 2-17, Paragraph 1 of the Electric Business Act.

The Ministry of Economy, Trade and Industry issued a business improvement order to Chubu Electric Mirai Co., Ltd. on July 14, 2023, based on the Electric Business Act.

On July 14, 2023, the Ministry of Economy, Trade and Industry issued a business improvement order to Kyuden Mirai Energy Corporation under the Electricity Business Act, Article 2-17-1, based on its assessment that such an order was necessary.

On July 14, 2023, the Ministry of Economy, Trade and Industry issued a business improvement order to Kansai Electric Power Co., Inc. under Article 2-17-1 of the Electric Business Act.

On July 12, 2023, the Ministry of Economy, Trade and Industry issued an administrative order for operational improvement to Kyushu Electric Power Co., Inc. under the Electric Business Act, following a review and consultation with the committee.

On July 12, 2023, Kansai Electric Power Co., Inc. was issued a business improvement order by the Ministry of Economy, Trade and Industry under the Electric Business Act, following a hearing with the committee.

On July 12, 2023, the Ministry of Economy, Trade and Industry issued an administrative order for operational improvement to Kyuden Mirai Energy Corporation under the Electric Business Act, following a hearing with the committee.

On July 12, 2023, the Ministry of Economy, Trade and Industry issued a business improvement order to Chugoku Electric Power Co., Inc. under the Electric Business Act, following a review and consultation with the committee.

On July 12, 2023, the Ministry of Economy, Trade and Industry issued an administrative order for operational improvement to Chubu Electric Mirai Corporation under the Electric Business Act, following a review and consultation with the committee.

Regarding pharmaceuticals (HMG Injection 75 IU 'Ferring' and HMG Injection 150 IU 'Ferring'), the Pharmaceuticals and Medical Devices Agency conducted an on-site inspection of the active pharmaceutical ingredient manufacturer, Instituto Massone S.A. (Argentina), in November 2022. It was confirmed that the manufacturer did not comply with the standards for manufacturing and quality control of pharmaceuticals and quasi-drugs (GMP Ordinance).

The company '株式会社big ones' was issued an administrative order for business improvement due to violations of the Act on Proper Management of Rental Housing and related regulations, including incomplete documentation, failure to segregate funds, and failure to report management activities in 17 contracts since June 15, 2021.

The Tokyo Metropolitan Government has provided information that Nihon Microport CRM Corporation has initiated a voluntary recall of the medical device listed below (patient monitoring).

An administrative order for business improvement was issued based on Article 72-4, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

An administrative order for business improvement was issued based on Article 72-4, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.

Issued an administrative disposition of business improvement order based on Article 72-4, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc.

An administrative order for business improvement was issued due to violations of reporting obligations for adverse reactions involving 57 prescription drugs containing 57 ingredients manufactured and sold by the company, caused by a malfunction in the adverse reaction reporting system, which resulted in 5,475 cases of reporting violations. Additionally, violations related to 28 ingredients' clinical trial drugs involving 154 cases of adverse reactions were identified due to the same system failure.