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Aqualex Co., Ltd., a South Korean drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in October 2023, particularly regarding the production of OTC sunscreen products and an unapproved drug product called "DBH Beverly Hills, EGF FGF DNA, UV Shield." The company failed to establish adequate written procedures for production and process control to ensure drug products had the identity, strength, quality, and purity they claimed, and did not provide validation data for manufacturing processes. Additionally, the firm introduced an unapproved new drug into interstate commerce and misbranded products in violation of the Federal Food, Drug, and Cosmetic Act.