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

On March 27, 2025, the FDA issued a Warning Letter to Yiling Pharmaceutical Ltd. following an inspection from October 7-11, 2024, at their facility in Shijiazhuang, Hebei, China. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Equipment Design and Maintenance (21 CFR 211.63):** Non-dedicated manufacturing equipment, specifically (b)(4), was not designed or maintained to prevent cross-contamination. Issues included a (b)(4) that did not consistently close tightly, leading to backflow of bulk drug powder into the (b)(4) duct, where residues of multiple drug substances, including (b)(4), were found. Degraded seals covered with tape were also observed on the (b)(4) duct junctions. The firm's response, which involved replacing parts and testing reserve samples only for the preceding drug substance, was deemed inadequate as it failed to test for all drug substances processed on the equipment and did not address long-term seal integrity. The FDA requires a CAPA plan for routine oversight, effective repairs, preventive maintenance, and technological upgrades.