Integra LifeSciences receives FDA warning letter for quality system violations at three facilities

INTEGRA LIFESCIENCES HOLDINGS CORP

FDA warning letter dated Dec 19, 2024, for quality system issues at Mansfield, MA; Plainsboro, NJ; Princeton, NJ facilities.
Products cited: cranial perforators, cottonoid patties, strips, collagen-based products; shipping holds and voluntary recall of patties/strips previously initiated.
Warning letter does not restrict manufacturing/shipment or require recall; premarket approval for related Class III devices blocked until violations resolved.
Company reaffirms Q4 revenue guidance of $441M-$451M; expects no material impact from warning letter.
Company is executing a compliance master plan and preparing a written response to the FDA.

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