Plate Loader Options for the CytoFLEX PlatformĬustomer Spotlight: Beckman Coulter Life Sciences had the honor of interviewing Weiming Shen, MS, ASCPCM, Manager of the Genomics Laboratory Service at Miami Cancer Institute, to discuss her team’s progress with virology research.ĭuring early 2020, Weiming Shen was conducting cancer genomic profiling and biomarker research as usual.
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The company did not respond to a request for comment. It is unclear if Beckman Coulter has done so. Robert Hurley responded to FDA's concerns in July and August, but the adequacy of his responses in many instances could not be determined due to a lack of documentation, proof of implementation of required procedures, or other factors, FDA said.įDA has asked Beckman Coulter to respond to its concerns within 15 days of receiving the warning letter with information about specific steps it has taken to address the violations and how it plans to prevent such violations, or similar ones, from occurring again. In addition, FDA said that the company had failed to report to the agency within a 30-day timeframe information that a device marketed by Beckman Coulter had malfunctioned "and would be likely to cause or contribute to death or serious injury if the malfunction were to recur."įDA's findings were based on inspections done at the Miami facility between Feb. The agency also determined that Beckman Coulter's DxH, LH, HmX, and Diff series of hematology analyzers, as well as reagents used on the analyzers, were misbranded "in that your firm failed or refused to furnish material or information" related to the devices. 1 and posted this week on FDA's website, the agency said that it had found that Class I and II in vitro diagnostic products manufactured at the site were "adulterated … and not in conformity with the Current Good Manufacturing Practice requirements" as defined by federal regulations.Īmong the myriad of violations noted by FDA investigators was a failure to create and maintain "adequate procedures for implementing corrective and preventive action " failure to establish and maintain adequate customer complaint procedures and failure to establish and maintain proper personnel training procedures. NEW YORK (GenomeWeb News) – The US Food and Drug Administration has issued a warning letter to Beckman Coulter citing issues it identified at the company's Miami facility. Advances in Clinical Genomics Profiling.
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