WalkMed Lands FDA Warning Letter Over Failure to Investigate Complaints
Failure to conduct adequate investigations of complaints related to its volumetric infusion pumps and not providing corrective action documents are among the issues that have landed WalkMed Infusion an FDA warning letter.
In a Nov. 2 warning letter that resulted from a May 18, 2015, to June 11, 2015, inspection of the company’s Centennial, Colo., facility, the FDA takes WalkMed to task for not adequately investigating complaints related to the failure of air-in-line detection systems in the Triton and Triton FP infusion pumps, or air being infused into patients. In addition, the company received complaints involving patient infusion-related reactions during use of the Triton administrations sets.
Although the company issued responses dated July 1, 2015, and Aug. 31, 2015, to the 483, the FDA has deemed them inadequate.
Lack of Details
“You state that complaints related to the air-in-line detection system were re-evaluated; however, you did not provide a justification for you failure to review all complaints cited on the Form FDA 483,” the letter states.
Further, the company refers to a corrective action report to explain why it hasn’t conducted additional investigation, but that report does not include an assessment for the adequacy of the testing equipment used or an explanation of the sufficiency of the overall testing parameters.
WalkMed also is taken to task for failing to detail how it will address particulate nonconformances with a certain unnamed supplier. “You also failed to provide a retrospective assessment on the scope of the problem and the potential impact on marketed product,” the letter states.
The FDA also finds fault with the company’s complaint handling procedure. “This record includes a drop-down completion form with no explanation to the employee on how to appropriately assess the question being asked (in all cases), nor does it specify which employee(s) (with or without specialized training) will perform certain assessments in the Complaint Handling Record,” according to the letter.
In addition, the company failed to analyze and identify the existing and potential causes of nonconforming product and implement corrective actions, the FDA says.
The warning letter also dings the company over procedural failures relating to validating and verifying device design, validating device software, and calibrating for accuracy and precision.
The FDA notes that the company has sent a third response, which, along with proposed field corrections, is pending review.
WalkMed did not respond to a request for comment by press time.
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