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

Yiling Pharmaceutical Ltd. in Shijiazhuang, Hebei, China, a manufacturer of human drugs, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning of non-dedicated equipment leading to potential cross-contamination, failure to test incoming components before use, and incomplete re-qualification of an active pharmaceutical ingredient supplier. These issues indicate a lack of control over manufacturing processes and material quality.