![]() But you have to go to the root cause," Culp said during remarks to stock analysts.Ĭulp said Danaher is overhauling Beckman Coulter's corporate environment to create greater discipline, accountability and simplicity at all levels of the operation. Beckman Coulter produces diagnostic chemistry analyzers, reagents, calibrators and controls that are used to detect diseases or other medical conditions.Ĭulp said the company is addressing the shortcomings raised by the FDA's inspection, but acknowledged "we have a lot of work ahead." The FDA said a May inspection showed the company failed to meet standards for good manufacturing practices and quality-control, particularly for a photometer-board redesign that went into production in March 2010. Food and Drug Administration recently cited Beckman Coulter for inadequate quality controls at its California plant. The quality problems recently identified with medical test equipment manufactured by Danaher Corp.'sīeckman Coulter unit will be fixed, but the corrections will take time and require greater commitment to accountability and standards than Beckman has shown in the past, Danaher CEO Lawrence Culp said Friday. (Substantial changes throughout with emphasis on comments about quality-control problems with Beckman Coulter's products.) ![]()
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