Import Alert on Gambro Lifted After Successful Inspections
The FDA has lifted an alert preventing the import of Sweden-based Gambro's Phoenix and Prismaflex renal care machines into the United States following re-inspection of the company's manufacturing facilities in Dasco, Italy, and Lund, Sweden. The agency confirmed that Gambro had addressed FDA's concerns cited in a January 2006 warning letter, and had substantially improved its quality systems worldwide.
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