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Beckman Coulter, Inc. (BEC) Gets FDA Warning Letter over Quality Issues


8/25/2011 9:11:21 AM

The FDA warns Beckman Coulter on multiple quality issues at its California manufacturing plant, including issues related to its Class 1 recall of an electrolyte assay in May. The FDA filed a Warning Letter against Beckman Coulter Inc. (NYSE:BEC) this month, detailing a long list of alleged quality issues surrounding the company's manufacturing facility. Based on an investigation of Beckman's Brea, Calif.-based facility, the watchdog agency found problems with design validation processes, design change processing procedures, personnel training and reporting and execution systems for corrective and preventative actions, among other complaints.

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