FDA 483 - Nanophase Technologies Corporation - January 09, 2026

An FDA inspection of Solesence, Inc. in Romeoville, IL, an API manufacturer, revealed that processes for the production of Active Pharmaceutical Ingredients were not followed in writing. Specifically, an operator began a batch without an issued batch record, and critical operating parameters were found to be outside specified ranges. These issues indicate a lack of adherence to established manufacturing procedures.