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.

The investigator also cited the firm’s failure to make sure all manufacturing process deviations were recorded and all critical process deviations were investigated and resolved. For example, a note in the firm’s batch record listed a violation and instructions to fine the operator at fault. However, there was no formal deviation report documented and the effects of the deviation on product quality were not evaluated.

In addition, the inspection revealed partially-completed batch records, blank batch production records that were pre-signed by an operator and batch records with data changes made with a pencil with no justification. Two process batch records were found for the same operation; one was only partially completed by the operator, while the second was completed by a different operator.

The agency called for the firm to conduct a full investigation into the extent of its inaccuracies in reporting and data records, and for a risk assessment of the effects of the violations on its products.

The agency placed the firm on import alert in early March because of the GMP deviations.