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jeudi 6 août 2020

WL Stason Pharmaceuticals, Inc. - JULY 08, 2020

2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

Your firm lacked controls necessary to assure the integrity of electronic test data. Specifically, you failed to implement sufficient controls to support the integrity of your data and to ensure that only appropriate individuals had administrative rights.

Notably, a demonstration performed during the inspection revealed that the computer operating the (b)(4) spectrophotometer (ID: L-563) was not secured such that data files could be deleted without the knowledge of your quality unit. This instrument was used for finished product release and stability testing for several drug products.

Your response was inadequate because it failed to include a comprehensive review of all laboratory instruments to determine whether all user roles are appropriate. You acknowledged that your software was not working as intended and you lacked the necessary knowledge or experience to troubleshoot the issue. You noted that you are pursuing remediation for the (b)(4) spectrophotometer. Your response was insufficient because it lacked a retrospective assessment into how system vulnerabilities may have impacted data integrity.

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...