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BBC Group Limited, a Chinese drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and manufactured unapproved new drugs, specifically L.O.L. SURPRISE! branded scented hand sanitizers that were misbranded and introduced into interstate commerce without approval. During a March 2021 inspection, the FDA identified significant violations including failure to implement proper controls over computer systems to prevent unauthorized changes to master production records and other manufacturing controls. The company's April 2021 response to the FDA's inspection findings was deemed inadequate for failing to provide sufficient detail or evidence of corrective actions necessary to achieve CGMP compliance.