Recipient: Gambro Dasco S.p.A.Product:Electromechanical dialysis control systems Date: 1/5/06 Letter acknowledges receipt of firm’s Oct. 24, 2005, response to FDA 483 but deems it inadequate. Letter notes that until alleged violations are corrected, the FDA may take steps to keeping imported devices in detention. Letter also includes alleged reporting violations. For example, review of the...Read More