Sterinova Inc. – FDA 483, May 26, 2026

An FDA inspection of Sterinova Inc. in Saint-Hyacinthe revealed significant deficiencies in their manufacturing processes and quality control systems. Observations included a failure to scientifically justify expiration dates based on stability testing, inadequate CAPA procedures for out-of-specification results and recurring mold contamination, and insufficient root cause investigations. Additionally, the firm lacked adequate finished product sampling and bulk drug product assay testing to ensure product quality and process control.