FDA 483 - Voyant Beauty, Inc. - May 30, 2025

Voyant Beauty, Inc., a contract OTC drug manufacturer in Etobicoke, received a Form 483 with three observations. The inspection revealed significant deficiencies in laboratory controls, component release procedures, and production and process controls, including issues with microbial testing, risk assessments for components, process validation, and cleaning validation. These failures indicate a lack of scientifically sound procedures and controls to ensure drug product quality and purity.