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Santa Clarita Firm Gets FDA Nod

TriMed Inc., an orthopedic medical device developer based in Santa Clarita, on Tuesday announced it received what’s called a closeout letter from the Food and Drug Administration. The letter, dated Oct. 11, effectively ends the FDA’s 483 warning letter received in June 2016, requiring the biotech company to improve quality management systems. A 483 letter from the FDA warns management that the company has in some way violated the Food Drug and Cosmetic Act, or related Acts, according to FDA.gov. In TriMed’s case, packaging procedures did not meet agency standards. The FDA also found that TriMed failed to investigate complaints involving the possible failure of its devices, conduct satisfactory risk analyses, and establish “corrective and preventive action” procedures, the letter said. TriMed went through a 24-month process required by the FDA to reorganize its quality management department for regulatory compliance. Reorganization efforts included staff additions, cross-training staff to comply with FDA and international regulations and hiring a supplier quality manager. Richard Lubin, director of global quality assurance and regulatory affairs for TriMed, now leads quality and regulatory affairs efforts, the company said. “We are confident these improvements mean continued patient safety and assurance for physicians who rely on our products. We remain dedicated to bringing innovative, state-of-the-art orthopedic solutions to the marketplace and patients,” David Medoff, chief executive of TriMed, said in a statement.

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