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.
Integra said it’s preparing a response to the March 6 warning letter and has already given detailed, monthly reports on its corrective actions to the federal safety watchdog.
We take the matters identified in the letter seriously,” Integra said in a regulatory filing, noting that since the inspection it has “undertaken significant efforts to remediate the observations and continues to do so.”
The warning letter isn’t expected to affect Integra’s books in in a material way, the company said, and doesn’t restrict its ability to make or sell products.