FDA EIR - Shandong Luxi Pharmaceutical Co., Ltd. - July 24, 2019

Shandong Luxi Pharmaceutical Co., Ltd. underwent a routine FDA comprehensive Good Manufacturing Practice (cGMP) surveillance inspection in Heze, China, from July 18 to July 24, 2019. This inspection, conducted under Compliance Program CPGM 7356.002F for Active Pharmaceutical Ingredient (API) Process Inspections, revealed six significant objectionable conditions primarily within the laboratory system. Major violations included insufficient and incomplete stability studies, specifically lacking complete impurity profiles for U.S. market products and annual stability batch placement. Critical laboratory records and electronic raw data from analytical software (ZWPro) and Excel calculation sheets were not consistently maintained. Laboratory control procedures were deemed inadequate, with discrepancies in water sampling methods, and a lack of comprehensive electronic data and audit trail review requirements. Moreover, laboratory procedures for media preparation were not followed, evident in missing pH adjustments, lack of growth promotion, and absent vendor qualification for certain media. Significant data integrity concerns were identified, such as unsecured HPLC systems allowing unauthorized data alteration and poorly defined user roles enabling analysts/reviewers to change raw data. Finally, electronic systems utilized for calculating release data, like Excel for purity/impurity and potency assays, were unvalidated. Management acknowledged these findings, which were communicated as potential violations of the Food, Drug and Cosmetic Act. They committed to providing a written response within 15 business days, outlining corrective actions. These include updating stability testing to U.S. standards, ensuring complete data retention, revising procedures for electronic data and audit trail review, validating media preparation processes, strengthening data system security and user role separation, and validating all electronic calculation tools.