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.

Get the complete picture with a MassDevice Plus membership. Registered users can login here.