FDA EIR - DSM Nutritional Products France SAS - September 16, 2016

A routine Good Manufacturing Practices (GMP) inspection by the FDA was conducted at DSM Nutritional Products France SAS, an active pharmaceutical ingredient (API) manufacturer, from September 12 to September 16, 2016. The inspection, guided by CPGM 7356.002F and ICH Q7 GMP for API processing, evaluated the company's Quality, Production, Facilities and Equipment, Laboratory, Materials, and Packaging and Labeling systems. The primary issue identified during this inspection concerned laboratory records, which were found to lack complete data from all necessary tests, examinations, and assays required to ensure adherence to established specifications and standards. Importantly, earlier deficiencies from a 2012 inspection —which involved inadequate water system monitoring, insufficient cleaning validation, poor sample traceability, and unaddressed equipment leaks—were confirmed as corrected or not recurring. The inspection concluded with a "Voluntary Action Indicated" (VAI) classification. The report was referred to the Center for Drug Evaluation and Research (CDER) for final classification and review. This classification requires the company to voluntarily address the identified deficiency in its laboratory record-keeping practices to maintain compliance with regulatory expectations for the active pharmaceutical ingredients it supplies to the United States market.