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AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp, a drug manufacturer in Dallas, Texas, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection from June to August 2024. The company failed to establish adequate laboratory testing procedures and release specifications for its over-the-counter topical drug products containing minoxidil before distributing them to market, resulting in adulterated drugs. Additionally, two hair restoration products—"Men's Lifecell Hair Restoration Solution Hair Regrowth Treatment Extra Strength" and "Women's Lifecell 2% Minoxidil Topical Solution USP Hair Regrowth Treatment"—were distributed as unapproved new drugs in violation of federal law.