(By Balaseshan) Integra Lifesciences Holdings Corp. (NASDAQ: IART), a medical device company, said its unit has received a warning letter from the U.S. Food and Drug Administration (FDA) related to quality systems issues at its manufacturing facility located in Andover, England.
Integra NeuroSciences Ltd. received the letter that resulted from an inspection held at the facility in June 2012. The company does not expect to incur material incremental expense during the fourth quarter on remediation activities.
The FDA determined that the company manufactures Intracranial Pressure Monitors and Ultrasonic Aspiration devices, which are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.
This inspection revealed that these devices are adulterated that are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.
The warning letter 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.
Despite providing detailed responses, the company did not provide completion dates or documentation to show that it had implemented these corrective actions. FDA said a follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
"Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance," said Steven Silverman, Director - Office of Compliance, Center for Devices and Radiological Health.
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.
IART closed Monday's regular session up 0.08% at $37.46. The stock has been trading between $23.09 and $43.12 for the past 52 weeks.