FDA has issued a warning letter to a subsidiary of Integra LifeSciences related to quality systems issues at the company's manufacturing facility in Boston, MA. Integra said the letter is the result of an inspection at the facility last October and November.
The letter does not identify any new observations beyond what was identified on the Form 483 that followed the inspection, Integra noted on a regulatory filing.
"We take the matters identified in the letter seriously and are in the process of preparing a written response to the letter," the company said in the filing. "The company has provided detailed responses to the FDA to its corrective actions on a monthly basis and, since the conclusion of the inspection, has undertaken significant efforts to remediate the observations and continues to do so."
The Boston facility manufactures extracellular bovine matrix products. Sales of products manufactured in the Boston facility constituted less than 4% of the company's consolidated revenues in the 12 months ended Dec. 31.
Integra said the warning letter does not restrict its ability to manufacture or ship products, and no products have been recalled. The letter also does not restrict the company's ability to seek FDA 510(k) clearance of new products. It does, however, mean that premarket approval applications for Class III devices to which the violations are reasonably related will not be approved until the violations have been corrected.