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

An FDA inspection conducted at SV Labs Toronto Corporation, a contract Over-the-Counter (OTC) drug manufacturer in Brampton, Canada, from May 20-23, 2025, revealed significant deficiencies across its operations. The inspection identified five key observations related to non-compliance with current Good Manufacturing Practices (CGMP). Major issues included the absence of adequate written procedures for production and process controls, leading to incomplete or non-existent validation documentation for numerous OTC drug formulations and critical manufacturing equipment. The firm also lacked proper cleaning validation programs, particularly for high-risk products and difficult-to-clean equipment, posing an elevated risk of cross-contamination. Inspectors noted inadequate maintenance and sanitization of equipment and facilities, exemplified by the presence of unidentified particulate matter and structural damage in a stability testing laboratory. Batch production and control records were found incomplete, lacking critical process details for filling operations. Furthermore, the laboratory control system showed significant flaws, including unqualified instruments and stability chambers, insufficient testing procedures, and a critical oversight in discontinuing routine testing for high-risk components based solely on supplier requalification. Crucially, the Quality Unit failed to effectively exercise its oversight responsibilities, neglecting to review essential quality documents for various CGMP activities. The company is required to implement comprehensive corrective actions, including enhancing product lifecycle oversight and establishing scientifically sound, data-driven qualification and validation programs to ensure product quality and patient safety, addressing these systemic quality failures.