FDA 483 - True Botanica, LLC - August 22, 2025

True Botanica, LLC, a manufacturer of homeopathic drug products in Hartland, WI, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish adequate production, process, and laboratory controls, including process validations, change control, component testing, and cleaning validation. Additionally, the firm lacked written procedures for stability testing of its homeopathic drug products, with several observations being repeats from a previous 2018 inspection.