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

During an inspection conducted from May 19-23, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Symrise, S. de R.L. de C.V. This document outlined significant observations regarding the company's compliance with manufacturing regulations for Active Pharmaceutical Ingredients (APIs) at its San Nicolas de Los Garza, Mexico facility. Key violations included a lack of procedures for investigating label reconciliation deviations and inadequate documentation for label handling. The firm failed to perform complete identity testing on incoming production materials and demonstrated a systemic failure of its quality unit to investigate and resolve critical Out-of-Specification (OOS) reports. Furthermore, Symrise could not provide data to demonstrate that its API manufacturing processes were validated, indicating an inability to ensure reproducible product quality. The FDA also noted the absence of a documented, ongoing stability testing program to monitor API characteristics and confirm appropriate storage conditions, along with a failure to include stability data in annual product reviews for 2023 and 2024. Finally, operators were found to deviate from pre-approved instructions by documenting adjustments on batch records improperly. These observations highlight multiple areas where the company's quality systems are deficient, requiring comprehensive corrective actions to ensure compliance with Current Good Manufacturing Practices and prevent the distribution of potentially compromised API to the United States.