FDA 483 - EO Products, LLC - October 23, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 07a7f16c-4c01-4350-b0a4-c21f53762115