FDA EIR - DSM Nutritional Products (UK) Ltd - September 19, 2019

A U.S. Food and Drug Administration (FDA) cGMP inspection of DSM Nutritional Products AG's Sisseln, Switzerland facility occurred from September 16 to September 19, 2019. This routine inspection focused on the manufacturing of non-sterile Active Pharmaceutical Ingredients (APIs) for the U.S. market, covering key areas such as Quality, Laboratory Control, Production, Equipment and Facilities, and Materials systems. The inspection was conducted under the framework of the Active Pharmaceutical Ingredient (API) Process Inspection guidance.

During the inspection, two deficiencies were identified and verbally discussed with company management, though no official FDA Form 483 (Inspectional Observations) was issued. These issues involved operators not being properly qualified for visual inspection of equipment, including a lack of visual acuity screening, and an apparent failure to qualify laboratory reference standards received from third-party suppliers according to the firm's standard operating procedures.

Despite these verbal observations, the overall inspection was classified as "No Action Indicated" (NAI), meaning no official enforcement action or written observations were deemed necessary by the FDA at that time. The company is expected to address the discussed deficiencies internally. The facility will be reinspected in the future as part of the FDA's workplan.