FDA EIR - BASF SE - July 30, 2013

This FDA inspection of BASF SE, an Active Pharmaceutical Ingredient (API) manufacturer located in Ludwigshafen Am Rhein, Germany, was conducted from June 24 to June 27, 2013. The inspection served as both a Good Manufacturing Practice (GMP) and Pre-Approval inspection, requested by the Division of Field Investigations in connection with a CDER review for API approval. The regulatory framework for this abbreviated inspection included FDA Compliance Policy Guides for Drug Process Inspections, API Process Inspections, and Pre-Approval Inspections, with ICH Q7A serving as a guiding standard. The inspection focused on the company's Quality and Production Systems. Notably, the report indicated that no major deficiencies were identified during the current assessment. Furthermore, an FDA-483, which lists objectionable conditions, was not issued. The inspection also verified that corrective actions for observations raised during a previous FDA inspection in March 2010 were successfully implemented. Given these favorable findings, the inspector recommended a "No Action Indicated (NAI)" classification, signifying that no further regulatory actions were required from this inspection.