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. Gambro will begin selling new Phoenix hemodialysis machines to U.S. customers as soon as possible.
The company has submitted a 510(k) application for a significant software upgrade for Prismaflex, and will re-introduce the renal monitor to the U.S. market upon approval. “We are very pleased with the results of the inspections and FDA’s decision to lift the Import Alert,” said Thomas Glanzmann, chief executive officer of Gambro.
“Critical to this outcome was our ability to successfully demonstrate to FDA our commitment to patient safety, compliance and regulatory cooperation as evidenced by the significant changes we have made throughout our company to our quality processes and procedures.”