Japanese Firm Shows Pattern of Unreported Lab Data on Released API Lots, FDA Warns
A Tokyo-based manufacturer of active pharmaceutical ingredients (APIs) failed to report all laboratory testing data on released lots, according to a warning letter from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).An agency investigator conducted a site inspection last November and found analyses with out-of-specification results went unreported, despite the data being obtained on the same date that the company, Yuki Gosei Kogyo, reported passing results in 2015 for the same lot released in the US.
As a result of the incomplete batch record, the firm’s quality unit failed to conduct a review of all data from testing the API lot prior to release. The FDA investigator also “documented the same pattern with other products not intended for the US market,” Francis Goodwin, acting director at the Office of Manufacturing Quality within CDER, wrote in the warning letter.
Further, the firm “acknowledged that a retrospective review conducted after the inspection found additional instances of unreported electronic data in original batch records,” Goodwin added.
Yuki Gosei Kogyo manufactures a total of six API types, according to its website.
The warning letter calls on the firm to bring in a qualified consultant for remediation and conduct a “comprehensive investigation into the extent of the inaccuracies in data records and reporting,” a current risk assessment and a plan for implementing corrective and preventive actions. Yuki Gosei Kogyo did not immediately respond to a request for comment.
Yuki Gosei Kogyo Co., Ltd. 7/17/18