FDA Warning Letter: You stated to our investigator that your software was not validated and lacked audit trails. (ucm614415)

This software is also used to document the completion of manufacturing steps on batch records, including [redact] amounts, manufacturing activities, and calculations. You stated to our investigator that this [redact] software was not validated and lacked audit trails.

In addition, your firm lacked adequate controls to ensure that actions are attributed to authorized individuals with unique and unshared login credentials. For example, our investigator observed that the login credentials of employee, [redact], were used to document the completion of several manufacturing activities on two drug product batch records dated March 17, 2021, and July 19, 2021. However, you stated to our investigator that [redact] has not been employed at the company since September 2019. Further, it was observed that login credentials including “[redact]” and “[redact]” were used to document the completion of several manufacturing activities. You stated to our investigator that these login credentials were shared by multiple employees. Shared login credentials are unacceptable, as this practice prevents the identification of specific individuals accessing a controlled system.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.

View the original warning letter.