Bacterin International, a medical device manufacturer based in Belgrade, Minnesota, received two warning letters from the United States Food and Drug Administration. In these warning letters, the company was admonished for manufacturing and quality issues surrounding two of its wound drains and a bone putty product.
Guy Cook is the CEO of Bacterin. In remarks shared with reporters, he said that the company had made several significant improvements in its manufacturing processes following an initial FDA inspection. He also noted that the FDA sent warning letters for manufacturing issues that the company was in the process of resolving.
In prepared remarks, Cook said, "We made the modifications and notified the FDA we were compliant. We respect the audit process. We embrace that. Audits are meant to make systems stronger and we will continue to work with the FDA to be in compliance and strengthen our internal systems."
One of the warning letters admonished the company for quality systems violations during manufacture of its OsteoSelect Demineralized Matrix Bone Putty. According to the FDA, one lot of the product was mislabeled, and three other lots had endotoxin tests that did not meet regulatory muster.
Its wound drain products (Elutia and Via) were cited due to quality control concerns. The FDA also noted that the company needs to improve its complaint handling process.
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