Loading…
BioLyte Laboratories manufactured unapproved drug products including silver gels, pain relief creams, and magnesium oil sprays that violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated products. The facility's methods, facilities, and controls for manufacturing, processing, packing, and holding did not conform to CGMP requirements under 21 CFR parts 210 and 211, and the products were also misbranded in violation of FDA regulations. The FDA conducted inspections at the Grand Rapids, Michigan facility in December 2019 and February 2020, identifying significant violations that made the introduction or delivery of these products into interstate commerce prohibited under the Federal Food, Drug, and Cosmetic Act.