11/13/2012 8:28:59 AM
Integra LifeSciences Holdings Corporation (IART: Quote) said Tuesday that on November 5 it received a warning letter from the U.S. FDA related to quality systems issues at its manufacturing facility in Andover, England. The warning letter, which is a result of an inspection at the facility in June 2012, does not restrict the company from manufacturing or shipping products or importing them into the U.S. and also does not require the recall of products. The company has provided detailed responses to FDA as to its corrective actions on a monthly basis and, since the conclusion of the inspection, has undertaken significant efforts to remediate the observations.
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