FDA 483 - Symrise, Inc - February 28, 2025

Symrise, Inc. in Goose Creek, South Carolina, an API manufacturer, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies primarily within the Quality Unit, including failures in risk assessment, change management, validation, equipment maintenance, material testing, and product quality reviews. Other issues involved inadequate cleaning validations, lack of hold time studies for intermediates, and insufficient laboratory controls.