FDA 483 - Formulated Solutions Cleveland LLC - April 12, 2024

Formulated Solutions Cleveland, LLC, an OTC drug manufacturer, received a Form FDA 483 following an inspection from April 8-12, 2024. The inspection identified one observation related to inadequate laboratory controls. Specifically, the firm failed to establish scientifically sound specifications and perform testing to ensure technical grade alcohol used as an ingredient in drug products met USP standards.