Integra LifeSciences reveals FDA warning letter over chronic wound treatment

Integra LifeSciences (NSDQ:IART) today revealed its receipt of a warning letter sent by the FDA last week about quality system issues at a Boston-area plant that makes products to treat chronic wounds … Plainsboro, N.J.-based Integra said the FDA inspected the plant last October and November, resulting in a Form 483 covering the problems found there. The facility makes extracellular bovine matrix products that accounted for less than 4% of Integra’s sales last year, the company said … read more