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Integra LifeSciences Corporation's subsidiary TEI Biosciences, a manufacturer of collagen-based wound care and soft tissue repair devices including the product Durepair, was cited for failing to comply with current good manufacturing practice (cGMP) requirements under the Quality System Regulation (21 CFR Part 820). The FDA inspection from March through May 2023 determined the devices were adulterated due to non-conforming manufacturing methods, facilities, and controls. In response, the company initiated a recall of all finished goods manufactured between March 1, 2018 and May 22, 2023, and committed to halting distribution until the facility achieved substantial compliance with quality system regulations.