FDA 483 - Zhejiang Longde Pharmaceutical Co., Ltd - April 12, 2024

Zhejiang Longde Pharmaceutical Co., Ltd, a contract manufacturer and sterilizer in Hangzhou, China, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate procedures for complaint handling, corrective and preventive actions, acceptance activities, nonconforming product control, and device history records. Additionally, the firm failed to properly identify product acceptance status and its personnel lacked familiarity with relevant USFDA regulations.