483 for U.S. Infusion Cites Issues with Reporting, Quality Control
The FDA handed U.S. Infusion a Form 483 for violations including failure to notify the agency within 30 days after learning of a device malfunction that could result in patient injury or death.
The South Miami, Fla.-based company, which does business as Truecare Biomedix-USA, develops imports and distributes IV poles and administration sets.
According to the Sept. 17, 2014, form, the company didn’t provide MDR malfunction reports to the FDA after receiving three complaints of potentially harmful leakage from its IV administration sets in 2012. The inspection also found that the firm failed to adequately document corrective and preventive actions.
The company’s complaint processing and reporting procedures also fail to identify the most likely cause of device malfunction, the form says. And U.S. Infusion didn’t try to determine if patients were involved in the incidents or if medical intervention was required as a result, the form adds.
Although the CAPA request said all defective sets are to be returned, the FDA found no documentation that the defective products were also destroyed.
Company President Marc Parness says all requirements have been met and the company is now in compliance with the FDA. Read the form at www.fdanews.com/03-05-15-USInfusion.pdf.