FDA EIR - BASF SE - July 13, 2018

A routine surveillance Good Manufacturing Practice (GMP) inspection of BASF SE, located in Ludwigshafen Am Rhein, Germany, was conducted by the FDA from July 9 to July 13, 2018. This inspection focused on the company's operations as a non-sterile active pharmaceutical ingredient (API) manufacturer, guided by the FDA's Compliance Program 7356.002F for Active Pharmaceutical Ingredients and ICH Q7 Good Manufacturing Practice Guidance. The comprehensive review covered six key systems: quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. The inspection concluded with the issuance of a three-item Form FDA-483, detailing significant observations. The identified deficiencies included a critical test method (PM00760) for purity and assay lacking the required precision standard for system suitability. Additionally, procedures for calibrating instruments were found to be either deficiently written or inadequately followed. A third observation highlighted the absence of established control procedures to validate the performance of manufacturing processes that could introduce variability in the packaging operation. Dr. Rainer Fendt, the company's Nutrition and Health Director Global Quality Compliance, acknowledged these inspectional observations. BASF SE is now required to promptly implement corrective actions to address these quality system shortcomings and submit a comprehensive response to the FDA within 15 business days, outlining their remedial plan.