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Home » Chinese Drugmaker’s Warning Letter Cites Data, Record Keeping Quality Issues
Chinese Drugmaker’s Warning Letter Cites Data, Record Keeping Quality Issues
Following a Form 483 inspection report that Jiangsu Hengrui Pharmaceuticals of China was found to be storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, the company has now received an FDA Warning Letter.