Chinese Drug Company Stays on Import Alert; FDA Found Bacteria on Antiseptic Wipes
Chinese drug manufacturer Jiangsu Province Jianerkang Medical Dressing will remain on import alert, and approval of new applications or supplements withheld, until it implements a robust quality system to comply with current good manufacturing practices (CGMP), said the Food and…
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Drug Administration in a warning letter sent July 30. A Sept. 2011 inspection had found numerous violations of CGMP including, among other things, bacteria on antiseptic wipes manufactured by Jainerkang intended for use on wounds. The firm’s Oct. 2011 response to the inspection lacked sufficient corrective actions, FDA said.