FDA 483 - Vi Jon, Inc. - September 14, 2010

An FDA inspection of Vi-Jon, Inc. in St. Louis, MO, an OTC drug and cosmetic manufacturer, identified a significant failure in their quality control processes. The firm did not conduct out-of-specification (OOS) investigations for Total Organic Carbon (TOC) in water samples that exceeded established limits. Furthermore, the company lacked a formal OOS procedure for investigating TOC deviations, indicating a critical gap in their manufacturing controls.