The FDA slapped Japanese API maker Yuki Gosei Kogyo with a warning letter, citing the Tokyo-based company for failing to report lab testing data on released lots.
The warning letter was in response to an inspection conducted at the company’s facility last November. During that inspection, an investigator with the regulatory agency uncovered that out-of-specification results on a batch of API’s went unreported even though other data recorded on the same date for the same lot indicated passing results.
Despite the conflicting results, the agency said the company’s quality unit failed to conduct a review of all its data before the lot was released to the U.S. The inspector also found evidence that the same issue occurred with other products to be distributed in other countries.
The agency also noted the company “acknowledged that a retrospective review conducted after the inspection found additional instances of unreported electronic data in original batch records.”
That review “only assessed laboratory data and did not assess all parts of your facility’s operation where CGMP information is generated and maintained. In addition, you failed to provide details of your review criteria and methodology,” the letter said.
The FDA recommended Yuki Gosei Kogyo hire a consultant for remediation and that a comprehensive investigation into its data record and recording issues be conducted. It also directed the company to implement a plan for corrective and preventative actions.