NEW YORK — Magnolia Medical Technologies said on Tuesday that it has successfully addressed manufacturing violations identified last year by the US Food and Drug Administration.
Last year, the FDA issued a warning letter to Magnolia after discovering a number of manufacturing violations with the company's 510(k)-cleared Steripath Gen 2 blood collection device, which is designed to divert and discard the first few milliliters of blood collected for culture in order to eliminate contaminates from the sample. The violations included Magnolia's failure to implement procedures to monitor and control the shelf life of the device.
Seattle-based Magnolia said Tuesday that the FDA completed an on-site field inspection during which the agency conducted a detailed review of each corrective action implemented by the company in response to the warning letter.
Magnolia said that the FDA determined that it had successfully addressed each item in the warning letter and that its quality system meets regulatory specifications. As a result, the FDA issued a formal close-out notification for the warning letter. Magnolia added that it also completed device lot-specific recalls that it voluntarily initiated.
"We appreciate the collaborative engagement with FDA and recent opportunity to review continued enhancements we have made to our quality system," Magnolia CEO Greg Bullington said in a statement.