FDA 483 - Yiling Pharmaceutical Ltd. - October 11, 2024

Yiling Pharmaceutical Ltd., located in Shijiazhuang, Hebei, China, was subject to an FDA inspection from October 7-11, 2024, resulting in a Form FDA 483. The inspection highlighted several critical deviations from current Good Manufacturing Practices (cGMP) for human drug manufacturing. Key observations included a lack of adequate equipment cleaning and maintenance, leading to potential cross-contamination. Specifically, visible drug substance residues and unidentified compounds were found on non-dedicated manufacturing equipment, affecting multiple U.S.-bound product batches.

Furthermore, the firm failed to adhere to proper material control protocols. Components, such as the excipient (b)(4) for (b)(4) tablets, were used without being sampled, tested for (b)(4), and released by the quality control unit. This directly contravenes requirements for ensuring raw material quality before use in drug products.

Finally, Yiling Pharmaceutical Ltd. demonstrated deficiencies in its supplier qualification program. The reliability of a supplier's certificate of analysis for an active pharmaceutical ingredient, (b)(4), was not adequately verified, indicating incomplete vendor qualification. These observations collectively point to systemic issues in contamination control, material management, and supplier oversight. Yiling Pharmaceutical Ltd. is required to promptly implement comprehensive corrective actions to address these findings and ensure full compliance with FDA regulations, thereby safeguarding the quality and safety of its drug products.