FDA 483 - Hebei Jingye Medical Technology Corp., LTD. - June 28, 2024

During an FDA inspection conducted from June 24-28, 2024, a pharmaceutical manufacturing firm located in Cangzhou, Hebei Province, China, received a Form FDA 483 citing significant observations regarding its quality systems. The primary issues identified centered on a systemic failure to adhere to established procedures and regulatory requirements for Active Pharmaceutical Ingredient (API) manufacturing. Key violations included a failure to document and explain deviations, specifically concerning change control. The firm neglected to notify regulatory bodies of numerous manufacturing process and critical material supplier changes since 2018, and failed to issue change controls or deviations for these changes. Additionally, stability samples were mishandled after a chamber breakdown, being stored under incorrect conditions without justification. The inspection also revealed a lack of proper evaluation for changes in critical material suppliers, potentially impacting API quality. Furthermore, the firm failed to establish adequate preventative maintenance schedules and procedures for critical equipment like microbial incubators and a backup stability chamber, which was uncalibrated. Finally, basic recording practices were deficient, with production equipment use logs and maintenance activities not documented contemporaneously. The firm is now required to respond to these observations with a comprehensive plan of corrective actions to address these quality system deficiencies and ensure compliance with regulatory standards for pharmaceutical manufacturing.