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Gambro AB, Stockholm, Sweden, and Gambro Renal Products, Inc., Lakewood, CO, Feb. 13 (Denver).

Publication: Warning Letter Bulletin
Publication Date: 01-MAR-06 		Format: Online
Delivery: Immediate Online Access
Full Article Title: Gambro AB, Stockholm, Sweden, and Gambro Renal Products, Inc., Lakewood, CO, Feb. 13 (Denver).(MEDICAL DEVICES)

Article Excerpt
During an Aug. 3-Sept. 1, 2005, inspection of the Lakewood, CO-site, an FDA investigator determined that the firm, which imports and distributes hemodialysis systems and accessories--namely, Gambro AB's Prisma Continuous Fluid Management System and the Prismaflex System--was promoting the products for indications other than their intended uses.

Furthermore, the company failed to submit MDRs to FDA with a copy to the manufacturer, within 30 calendar days of receiving or otherwise becoming aware of information that reasonably suggested the...

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