According to the MHLW, samples of dry cell culture Japanese encephalitis vaccine manufactured by Kaketsuken were reported to have been produced by methods different from the approved methods. Though it was confirmed by experts that the modifications do not affect the quality and safety of the final formulation, this is a further blow to the credibility of this company. On January 8, 2016, MHLW had ordered Kaketsuken to stop business for 110 days for concealing changes in the manufacturing methods of plasma derivatives.
Nikkei Biotech news release, October 5, 2016
Chemo-Sero-Therapeutic Research Institute again under fraud suspicion for Japanese encephalitis vaccine production