Integra LifeSciences Holdings Corporation has announced that on November 5, 2012 it received a warning letter from the United States FDA related to quality systems issues at its manufacturing facility located in Andover, England.
The letter resulted from an inspection held at that facility in June 2012. The Company has provided a copy of the warning letter as an exhibit in a Current Report on Form 8-K filed concurrently with the issuance of this press release.
Serious as a warning letter from FDA sounds (and indeed can be), this one does not restrict the company’s ability to manufacture or ship products or import them into the United States. It 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, details of which have not been disclosed.
The Andover facility manufactures components of the CUSA ultrasonic aspirator system, and intracranial pressure monitors. Sales of products manufactured in the Andover facility constituted less than 3% of Integra’s consolidated revenues in the twelve months ended September 30, 2012.
The Company does not expect to incur material incremental expense during the fourth quarter on remediation activities.
Source: Integra Lifesciences Corporation, Globe Newswire