Japanese API maker accused of falsifying data by US FDA
The US Food and Drug Administration (FDA) inspection of Daito Kasei’s facility in Okayama, Japan in July last year resulted in a warning letter issued to the firm highlighting significant deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API).
The letter, sent earlier this month, accused the API maker of failing to ensure thatappropriate laboratory tests were conducted to determine conformance to specifications.
“You released numerous drugs without completing all required testing. You claimed that the drugs were tested for identity and assay, and met required specifications for these attributes,” the FDA said. “However, these tests were never conducted, so you had no assurance that the drugs conformed to specification.”
The firm was also found to have falsified certificates of analysis (COA) issued to its customers.
“Regulators and customers rely on COA for accurate information about the quality and sourcing of drugs and their components. Falsifying information about the quality of your drugs on COA compromises supply chain accountability and traceability, and may put consumers at risk.”
As such, the Agency has asked Daito Kasei to provide a comprehensive investigation into the extent of the inaccuracies in data records and reporting, and a current risk assessment of the potential effects of the observed failures on the quality of its drugs.
The firm did not respond to in-Pharmatechnologist for comment.
