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Linghai ZhanWang Biotechnology Co., Ltd, a Chinese manufacturer of over-the-counter drug products including anti-microbial wipes, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company did not adequately test components for identity, purity, and quality as required by FDA regulations—specifically, it failed to test its active ingredient ethanol for methanol content and did not demonstrate the purity and quality of components used in drug manufacturing. These manufacturing and quality control deficiencies resulted in the company's drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act.