FDA 483 - Shandong Xinhua Pharmaceutical Company Limited - March 25, 2019

Shandong Xinhua Pharmaceutical Company Limited, an API manufacturer in Zibo, China, was inspected and found to have significant deficiencies across its quality system. The firm failed to adequately investigate out-of-specification results, maintain control over critical manufacturing and laboratory records, and properly implement corrective and preventive actions or change controls. Additionally, the quality unit demonstrated deficient oversight of laboratory electronic systems and data integrity practices.