The Japanese health ministry inspected the facilities of Chemo-Sero-Therapeutic Research Institute, or Kaketsuken, a major manufacturer of blood products and vaccines, after an investigative panel accused the drugmaker of using unauthorized additives and falsifying records.
The third-party panel, set up after allegations of misconduct surfaced in May, found that since 1974, Kaketsuken has been producing blood products using improper production processes. Furthermore, the company began falsifying production records for national inspections around 1995.
According to allegations, the company went as far as to artificially age fake documents exposing them to ultraviolet radiation in order to produce the needed historical paper trail.
Headquartered in Kumamoto, Japan, Kaketsuken works with leading drugmakers Daiichi Sankyo and Takeda Pharmaceuticals. All of Kaketsuken's directors, including Director-General Seiji Miyamoto, will step down to take responsibility.
Read the Japan Times article