FDA 483 - Western Innovations, Inc. - April 30, 2025

Western Innovations, Inc. received a Form 483 with 26 observations detailing significant deficiencies in their dietary supplement manufacturing processes. The inspection revealed a pervasive lack of established specifications for components and finished products, along with inadequate batch and master manufacturing records. Furthermore, the firm exhibited poor sanitation practices, issues with equipment maintenance and calibration, and a critical absence of essential written procedures for quality control, manufacturing, packaging, and laboratory operations.