FDA Cites Sekisui Medical Co. for Deleting Data and Unverified Test Methods

Sekisui Medical Co., Ltd has received a warning letter after an inspection in June revealed significant data integrity issues.

An investigator found that the Japanese firm failed to maintain complete data from all laboratory analyses and discovered numerous data files in the recycle bin folder on a computer connected to instruments that test the purity of a medication. Records also show that the firm retested the lot without documented justification or an investigation and only retained the final test results.

In addition, investigators discovered that laboratory systems lacked controls to prevent deletion of and alterations to electronic raw data. The firm’s analyst demonstrated to the investigator that he could change the data, including injection time and date, without the changes being captured in the audit trail, prior to printing the results.