MYA International, Inc. Warning Letter Details

Summary

MYA International, Inc. marketed multiple products including Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, and others as unapproved new drugs and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act. The company's product labeling made disease claims—such as statements that Hygly and Diapro-Z were designed to stabilize blood glucose problems, reduce insulin need, and regulate blood sugar levels—that established these products as drugs requiring FDA approval, which they lacked. FDA conducted an inspection of the Chula Vista, California facility from August 30 through September 10, 2021, and identified these significant violations through review of product labels in the company's 2021 catalog.