Blood product maker Kaketsuken hit by record 110-day business suspension order


The health ministry on Friday ordered the Chemo-Sero Therapeutic Research Institute, or Kaketsuken, to suspend operations for 110 days after it was found using unauthorized methods to make blood products.

The business suspension order is the longest ever imposed under the pharmaceuticals and medical devices law, surpassing the 105 days issued to a drug maker that underreported deaths caused by the combined use of the antiviral drug sorivudine with a cancer drug.

The suspension from Jan. 18 to May 6 was issued because of the institute’s tendency to conceal misconduct over a long period. Given the potential impact on patients, however, a total of 27 items including blood products and vaccines lacking substitutes were excluded from the order, leaving only only eight products suspended.

Kaketsuken filed no objection to the order, the ministry said.

Based in Kumamoto, Kaketsuken had been manufacturing blood products using unauthorized methods since 1974, according to a third-party committee set up by Kaketsuken. The institute made systematic attempts to avoid government inspections by compiling false manufacturing records starting around 1998.

Following the third-party panel’s conclusions, the institute imposed penalties — including forced resignations and demotions — in December on all nine of its board members, including chief Seiji Miyamoto. The ministry conducted an on-site inspection to uncover the true nature of the wrongdoing.

The ministry ordered the institute to stop shipping blood products in June 2015, when the use of the unauthorized methods came to light. That September, it asked Kaketsuken to voluntarily refrain from shipping vaccines as well. The use of unauthorized methods was also confirmed in its animal vaccines, prompting the farm ministry to conduct an on-site inspection as well.

The ministry only approved shipments for vaccines that could be proven safe, including one for influenza. But that caused temporary shortages, forcing medical institutions to postpone certain vaccinations.

The health ministry also issued five business improvement orders to Kaketsuken on Friday after it was found to have transported the botulinum toxin without the required notification. One of the five orders demands advance checks be conducted by a safety management committee at the institute when it transports particular pathogens.

The unreported transportation of the highly toxic substance was revealed by an internal investigation at the institution on Dec. 7. The ministry also conducted an on-site inspection related to the case for two days from Dec. 21.