NEW YORK — The US Food and Drug Administration this week issued a letter to Magnolia Medical Technologies warning the company that it has failed to address manufacturing violations with its Steripath Gen 2 blood collection device.
If the issues are not corrected promptly, the FDA said, it may take regulatory action.
Steripath Gen 2 is designed to divert and discard the first few milliliters of blood collected for culture, which is the portion most likely to contain contaminants. It was cleared by the FDA in early 2020.
In its letter, the FDA said that an inspection of Magnolia's operations in mid-2021 uncovered violations of current good manufacturing practice requirements including failure to implement procedures to monitor and control the shelf life of the Steripath Gen 2 device. While Magnolia responded to the FDA's observations the following month, the agency said in its letter that the company's response has been inadequate.
Seattle-based Magnolia is required to provide the FDA with specific steps it has taken to correct the violations, as well as a plan to prevent future violations, the agency said. "Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," it added. "These actions include, but are not limited to, seizure, injunction, and civil money penalties."