NEW YORK, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of New Jersey on behalf of all persons or entities who purchased Integra Lifesciences Holdings Corporation ("Integra" or "Company") (NASDAQ:IART) between March 11, 2019 through May 22, 2023, both dates inclusive (the "Class Period").
Integra develops regenerative tissue technologies and neurological solutions. The Company's Tissue Technologies business—which generates approximately one-third of Integra's total revenue—manufactures and sells collagen-based medical devices that are used for complex wound care, peripheral nerve repair, and reconstruction surgery.
According to the Complaint, on October 9, 2018, the FDA began an inspection in the Boston Facility during which it observed that Integra's quality systems and manufacturing conditions were "not in conformity with the current good manufacturing practice requirements of the Quality System Regulation." The Complaint also alleges that as a result, 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.
The Complaint further alleges that after receiving the 2018 Form 483, Integra issued a series of responses purporting to address the problems identified by the FDA. According to the Complaint, on March 6, 2019, after concluding that Integra's responses were "not adequate to address the . . . violations," the FDA issued a warning letter (the "2019 Warning Letter") further documenting the quality control and manufacturing problems at the Boston Facility and noting that the "deficiencies observed during our inspection are ...
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