Warning letter: FDA unleashes laundry list of accusations against Beckman Coulter

August 24, 2011 by MassDevice staff

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.

Beckman Coulter

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.

The new warning letter also detailed problems related to Beckman's Synchron test, a computer-controlled electrolyte analyzer that recently underwent a Class I recall for reading false electrolyte levels.

The FDA's letter cited issues in storage procedures as well as post-recall monitoring inadequacies.

The warning letter is more bad news for Danaher Corp. (NYSE:DHR), which agreed to acquire the company in a deal valued at about $6.8 billion earlier this year.

A Beckman Coulter spokesperson told Law360.com (paid) that the company has a program in place to address all the FDA's concerns, and that the company is "absolutely committed to fixing the issues and working in full compliance with all regulations."

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