Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
The company announced in an SEC filing that it received the warning letter on December 19, 2024, that outlined issues identified during FDA inspections at three of its facilities in Mansfield, Massachusetts, Plainsboro, New Jersey, and Princeton, New Jersey.
Integra Lifesciences previously received an FDA warning letter in August 2023 when the agency found that the company inadequately responded to violations at its TEI Biosciences plant in Boston. The FDA’s new warning letter did not identify any new observations not already filed in the Form 483s previously issued by the company following the three inspections in June and August of 2024.
Integra said the FDA deemed specific devices, including cranial perforators, disposable cottonoid patties, strips, and collagen-based products, to be out of compliance concerning the quality system regulation. As a result, the company placed shipping holds on several products and issued a voluntary recall of the disposable patties and strips.
The FDA did not restrict the company’s ability to manufacture or ship products. It also did not require the company to recall any products or limit its ability to obtain FDA 510(k) clearance of products. The warning letter said that premarket approval applications for Class III devices that are “reasonably related” to the quality system regulation violations will not be approved until the violations have been corrected.
Integra Lifesciences said in the SEC filing that it submitted several responses to the Form 483s issued to each of the three manufacturing facilities. It is in the process of preparing a written response to the warning letter.
“The company takes the matters identified in the warning letter very seriously and is committed to working with the FDA to resolve them and continue its comprehensive efforts to remediate the observations. The company announced in July 2024 that it would initiate a comprehensive compliance master plan, a systematic and holistic approach to improving its quality management system across its manufacturing and supply network,” Integra Lifesciences said in the SEC filing.
Integra also said it is unaware of any additional actions stemming from the warning letter that would have a material impact on operational or financial expectations announced in the past. It reaffirmed its fourth-quarter revenue guidance range of $441 million to $451 million.
