FDA WARNING_LETTER - Sante Manufacturing Inc. - July 01, 2025

On June 5, 2026, the FDA issued a warning letter to Sante Manufacturing Inc. following a records review initiated in July 2025 for its facility in Ontario, Canada. The review revealed significant violations of Current Good Manufacturing Practice (CGMP) standards, rendering the firm"s over-the-counter drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Primary issues included the failure to test raw materials for identity—specifically high-risk components prone to dangerous contamination—and an over-reliance on supplier documentation without independent verification. Additionally, the firm failed to qualify its water system and lacked an adequate process validation program to ensure product consistency. The Quality Control Unit was also found deficient for failing to oversee stability testing and analytical method validation. Due to these risks, the FDA placed the firm on an import alert in April 2026. Required actions include providing immediate contamination test results for high-risk ingredients, conducting a comprehensive risk assessment for all products currently on the market, and implementing robust procedures for component testing and system validation. The FDA also strongly recommended that Sante hire an independent consultant to audit their operations and assist in achieving regulatory compliance.