FDA EIR - Shandong Qilu King-phar Pharmaceutical Co., Ltd. - April 24, 2015

An FDA CVM GMP Surveillance Inspection was conducted at Shandong QiLu King-Phar Pharmaceuticals Co. Ltd. in Jinan, China, from April 20-24, 2015. The inspection focused on the manufacturing of non-sterile Active Pharmaceutical Ingredient (API) for the US market, regulated under the FD&C Act Section 501(a)(2)(B) concerning animal drugs, following CPGM 7371.001 guidance. The inspection concluded with no significant deficiencies impacting product quality, and no Form FDA 483, List of Observations, was issued. The firm's previous 2011 inspection findings were confirmed to have been fully addressed. However, several non-critical observations were discussed with management during the closing meeting. These included the need to monitor personnel entry logs for certain buildings, the immediate installation of a metal tray to prevent liquid spillage from equipment, and the implementation of a regular maintenance schedule for the facility's building and premises. The spillage issue was corrected on-site before the inspection concluded, and the firm committed to addressing the other observations. The company provided full access to all requested documents and personnel throughout the inspection.