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Talk to a SpecialistTalk to a SpecialistWestern Innovations, Inc. manufactured adulterated dietary supplements (Acetyl-glutathione) that violated Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Part 111. The company failed to establish proper component specifications, including identity specifications for dietary ingredients such as silica mineral hydride complex, and the analytical methods provided by suppliers lacked sufficient specificity for ingredient identification. An FDA inspection conducted from January 29 through February 21, 2024, at the Denver, Colorado facility identified these significant CGMP violations that rendered the manufactured dietary supplements non-compliant with federal food and drug regulations.