Chinese Firm Warned for Data Integrity, Record Maintenance Issues

The FDA issued a warning letter to Jilin Shulan after an inspection of the firm’s Shulan City, Jilin Province facility revealed significant GMP deviations for active pharmaceutical ingredients.

The investigator found that audit trails for the firm’s HPLC, gas chromatography and infra-red systems were not enabled, there were no mechanisms for recording and monitoring data changes, and the systems allowed full access, including the ability to change and delete files.

Although electronic data from the instruments was backed up to a portable drive, the drive had no password protection and was left in an unlocked office drawer.