FDA EIR - DSM Nutritional Products (UK) Ltd - January 25, 2018

An FDA inspection of DSM Nutritional Products AG, located in Sisseln, Switzerland, was conducted from January 22 to January 25, 2018. This cGMP inspection focused on the company's non-sterile Active Pharmaceutical Ingredient (API) manufacturing processes, following the guidelines of CPGM 7356.002F for API Process Inspections. The inspection covered five key systems: Quality, Facilities & Equipment, Production, Materials, and Packaging & Labeling. It was noted that the Sisseln site has not manufactured products for the U.S. market since a previous inspection in January 2016. Despite this, the inspection verified corrections for prior verbal observations, which were found appropriate. While no formal FDA 483 document listing observations was issued, three verbal observations were discussed with management. These included the absence of defined timeframes for initiating investigations, insufficient identification of the origin for a moist product sample from a centrifuge, and the lack of independent label reconciliation by personnel other than the operator. The inspection concluded with a 'No Action Indicated' classification, suggesting that formal regulatory actions beyond addressing these verbal points are not required.