FDA EIR - BASF SE - March 10, 2016

An FDA routine Good Manufacturing Practice (GMP) inspection was conducted at BASF SE in Ludwigshafen, Germany, from March 7 to March 10, 2016. This pre-announced, comprehensive inspection focused on the firm's Active Pharmaceutical Ingredient (API) manufacturing processes, particularly for products shipped to the U.S. market, including (b)(4) and other (b)(4) distributed as (b)(4). The inspection comprehensively covered quality, materials, production, and laboratory systems, with additional, limited review of facilities, equipment, packaging, and labeling. It was performed under the regulatory framework of Compliance Program CP 7356.002F, specifically for Active Pharmaceutical Ingredient process inspections, and adhered to ICH Q7A guidance. A significant finding of this assessment was the absence of major objectionable conditions. Consequently, no FDA-483, which signals inspectional observations, was issued to BASF SE. The inspection was classified as "No Action Indicated" (NAI), signifying that the facility was found to be in compliance with applicable GMP regulations at the time of the inspection. No specific violations were identified, and no mandatory corrective actions were required from the company based on this inspection. A routine follow-up inspection is scheduled for March 2018.