FDA 483 - Shandong Analysis and Test Center - January 16, 2017

Shandong Analysis and Test Center, a contract testing laboratory in Jinan, China, was cited for significant deficiencies in its quality unit's control over electronic laboratory systems and data integrity. The inspection revealed issues with unvalidated software, lack of audit trails, shared access, incomplete laboratory records, and inadequate analytical method validation. These findings indicate a serious lack of control over critical data and testing processes.