FDA 483 - EO Products, LLC - October 23, 2025

An FDA inspection of EO Products, LLC in San Rafael, CA, revealed significant deficiencies across multiple systems. The firm failed to conduct adequate investigations into out-of-specification results and customer complaints, lacked validated testing methods and long-term stability studies, and exhibited inadequate control over component testing, in-process sampling, equipment calibration, and facility segregation. These issues indicate a systemic failure to adhere to cGMP requirements for OTC drug manufacturing.