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Talk to a SpecialistTalk to a SpecialistIntegra LifeSciences Corporation's neurological, neurosurgical, and collagen-based medical devices (including cranial perforators, cottonoid patties, and wound care products) manufactured at three facilities in Massachusetts and New Jersey were found to be adulterated due to non-conformance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. FDA investigators and a microbiologist identified deficiencies in the methods, facilities, and controls used in the manufacture, packing, storage, or installation of these devices during inspections conducted between March and August 2024. The company submitted multiple responses to the FDA 483 inspection observations in June, August, and October 2024 but failed to achieve compliance with quality system regulations.