Sato Kogyo Co. Ltd., of Kashihara City, Japan, received an FDA warning letter citing concerns about data integrity. The letter stems from a June inspection in which an FDA investigator noted audit trails indicating duplicate testing for impurities, within a 24-hour period, in the plant's high performance liquid chromatography system. There was no justification given for the repeat testing, and data from the first analysis were not maintained. To resolve the concerns, the FDA instructed the company to conduct a comprehensive investigation into the extent of the inaccuracies in its data records and reporting and to complete a current risk assessment of the potential effects of the data failures on the quality of the company's drugs.