FDA 483 - SV Labs - October 23, 2025

During an inspection conducted by the FDA from October 20-23, 2025, SV Labs Corporation, a contract manufacturer in Watsonville, CA, was issued a Form FDA 483 detailing five significant observations regarding their compliance with drug manufacturing regulations. Key issues included a lack of appropriate controls over computer systems and unvalidated software critical for batch release and inventory management. The firm failed to conduct identity testing for incoming drug components, including Active Pharmaceutical Ingredients (APIs), and did not adequately establish the reliability of supplier certificates of analysis, relying on limited in-house tests. Furthermore, supplier qualification records for APIs were absent. Production system deficiencies were noted, specifically the failure to calculate actual and theoretical yields in batch production records for various drug products. Lastly, the quality system lacked written procedures for conducting annual product reviews, which are essential for evaluating product quality standards, addressing complaints, recalls, deviations, and stability data. SV Labs Corporation is required to promptly address these observations to achieve compliance with FDA Good Manufacturing Practices.