FDA 483 - Mother Earth Minerals, Inc. - August 15, 2024

Mother Earth Minerals, Inc. in Ogden, UT, was inspected regarding its dietary supplement manufacturing operations. The inspection revealed numerous fundamental deficiencies across all aspects of its quality system, including a complete lack of product and component specifications, master manufacturing records, batch production records, and written procedures for nearly all critical operations. These widespread failures indicate a severe lack of control over the manufacturing, packaging, labeling, holding, and distribution of their dietary supplements.