FDA 483 - Sigan Industries Group Inc. - May 23, 2025

SV Labs Toronto Corporation, a contract OTC drug manufacturer in Brampton, was cited for significant deficiencies across its production, laboratory, and quality control systems. The inspection revealed inadequate validation programs, poor equipment maintenance leading to contamination risks, incomplete batch records, and a failure of the Quality Unit to properly oversee manufacturing operations. These issues indicate a systemic quality failure that has persisted since a previous inspection.