IART - INTEGRA ALERT: Bragar Eagel & Squire P.C. is Investigating Integra LifeSciences Holdings Corp. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm | Benzinga
NEW YORK, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Integra LifeSciences Holdings Corp. (NASDAQ:IART) on behalf of long-term stockholders following a class action complaint that was filed against Integra on September 12, 2023 with a Class Period from March 11, 2019 to May 22, 2023. Our investigation concerns whether the board of directors of Integra have breached their fiduciary duties to the company.
The claims against Defendants arise from the Company's violations of federal manufacturing regulations governing medical devices, which are intended to protect patients receiving these medical devices from infections and other medical complications. In October 2018, the FDA inspected the Boston Facility and found that Integra was in violation of the good manufacturing practice requirements of the Quality System Regulation. Consequently, on November 2, 2018, the FDA issued a Notice of Inspectional Observations on Form 483 (the "2018 Form 483") to put Integra on notice of those violations. Most significantly, the FDA found that Integra failed to adequately test for bacterial endotoxins in the medical devices manufactured at the Boston Facility. On March 7, 2019, Integra received a warning letter (the "2019 Warning Letter") from the FDA that detailed the Company's continued failure to remediate the violations that the FDA identified in the 2018 Form 483.
Since 2018, Integra has received multiple warnings from the FDA that its Boston Facility is not in conformity with the good manufacturing practice requirements of the Quality System Regulation. However, throughout the Class Period, Defendants assured investors that they had "undertaken significant efforts" ...