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

Shandong Analysis and Test Center, a contract testing laboratory, was cited for significant deficiencies in its quality unit's control over laboratory electronic 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 observations indicate a serious lack of control over critical laboratory operations and data.