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FDA Warns Beckman Coulter About Quality System Issues

NEW YORK – The US Food and Drug Administration on Tuesday posted a warning letter to Danaher subsidiary Beckman Coulter about quality system issues at one of the firm's manufacturing sites. 

The letter, dated March 15, noted that during an inspection last year at Beckman Coulter's Chaska, Minnesota, manufacturing site for its DxI 9000 immunoassay analyzers, the FDA discovered that the "methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation." 

The violations listed in the letter include failure to adequately establish and maintain procedures for risk analysis, failure to adequately establish procedures for corrective and preventative actions, failure to adequately establish procedures to control product that does not conform to specified requirements, and failure to adequately establish procedures for design change. 

Beckman Coulter provided two responses to the FDA's inspection results in January and February, and the agency said that the responses are not adequate to address the first issue related to risk analysis procedures. While Beckman Coulter did provide information about the actions it is taking to address its failure to establish procedures for corrective and preventive actions, design change, and to control nonconforming products, the FDA said that the adequacy of the responses can't be determined because the responses don't provide specific information on the results of the actions the company is taking. 

The FDA said in its warning letter that Beckman Coulter has 15 days to respond to the letter and that its response should include the specific steps Beckman Coulter has taken to address the noted violations and an explanation of how the company plans to prevent the violations from occurring again.