Japanese API Maker Draws FDA Warning for Data Integrity Failures

The FDA warned API manufacturer Yuki Gosei Kogyo about major data integrity violations observed during a Nov. 13-17 inspection of its facility in Fukushima, Japan.

The agency found the company failed to ensure complete product testing data was included in the official batch record and reviewed by the quality unit.

The company reported passing results for related substances testing for at least one lot in July 2015, but investigators found unreported analyses including out-of-specification results for the same lot. It did not include the data for review by its quality unit ahead of the lot’s release, the agency said.