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Medical Devices / Inspections and Audits

Dialysis Solutions Company Sold Faulty Products, FDA Says

Oct. 13, 2017
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A company that manufactures and repackages solutions used in kidney dialysis was cited by the FDA for selling products that failed quality tests and had not been cleared in reinspections before shipping, according to a warning letter from the agency.

The letter, issued to Diasol, of San Fernando, California, was based on visits by FDA inspectors in May and June to the company’s facility in Phillipsburg, New Jersey.

The letter pointed to two different batches of solution that were shipped despite lab tests recording excessive concentrations of sodium and a third batch shipped despite tests showing an excessive concentration of magnesium. It also flagged a shipment of solution for which the test results were dated after the shipment and initialed by a quality manager in San Fernando.

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