Beckman Must Boost Lab Device Quality Practices: FDA
By Martin Bricketto (August 23, 2011, 3:18 PM EDT) -- The U.S. Food and Drug Administration has accused lab equipment maker Beckman Coulter Genomics Inc. of inadequate design validation and corrective and preventive action violations based on an investigation at the company's Brea, Calif., facility, according to a warning letter released Tuesday.
The FDA's Aug. 9 warning letter to the company, which was recently acquired by Danaher Corp., concerns Beckman Coulter's diagnostic chemistry analyzers, reagents, calibrators and controls.
A federal inspection of the facility between March and May revealed that, in some cases, methods, facilities or controls associated with the devices failed to conform to current good manufacturing practice requirements under...
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