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.
In a letter dated Nov. 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.
Among 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.
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.
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."
FDA's findings were based on inspections done at the Miami facility between Feb. 28 and June 2. Beckman Coulter President and CEO J. 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.
FDA 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.
It is unclear if Beckman Coulter has done so. The company did not respond to a request for comment.
In August FDA sent a warning letter to Beckman Coulter about violations it found at its facility in Brea, Calif., in connection with its AccuTnl troponin test kits that run on its UniCel DxI immunoassay system.