FDA 483 - Symrise, S. de R.L de C.V. - May 23, 2025

Synrise, S. de R.L. de C.V. in San Nicolas de Los Garza, Mexico, was cited for multiple significant deficiencies in its manufacturing processes and quality control. The inspection revealed failures to investigate critical deviations, establish proper procedures for investigations, adequately test incoming materials, and ensure quality unit oversight of OOS reports and annual product reviews. Additionally, the firm lacked validated manufacturing processes, a documented stability testing program, and adherence to pre-approved batch records.