Suzhou Xishan Zhongke Drug R&D, Co. Ltd. – FDA 483, May 10, 2024

An FDA inspection of Suzhou Xishan Zhongke Drug R&D, Co. Ltd., a nonclinical laboratory in Suzhou, revealed significant deficiencies in their operations. Observations included inadequate archiving and access controls for study records, insufficient written standard operating procedures for data quality, and failures in quality assurance unit responsibilities and equipment maintenance.