Loading…
Fancystage Unipessoal, LDA, a Portuguese drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceuticals, including an OTC sodium fluoride mouthwash product. The company failed to adequately test incoming components for identity and conformity with specifications, and did not validate or establish the reliability of its component suppliers' test analyses at appropriate intervals, rendering its drug products adulterated. Additionally, "THE HUMBLE CO. sodium fluoride 0.05% anticavity mouthwash FRESH MINT" was determined to be misbranded under federal law. The FDA found the company's February 2024 response to inspection findings inadequate due to lack of supportive documentation and insufficient evidence of corrective actions to achieve compliance.