Levi & Korsinsky, LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or otherwise acquired Integra LifeSciences Holdings Corporation (NASDAQ: IART) securities.
If you suffered a loss on your Integra investment and would like to explore a potential recovery under the federal securities laws, submit to us or contact Joseph E. Levi, Esq. via email at [email protected] or call 212-363-7500 to speak to our team of experienced shareholder advocates.
THE LAWSUIT: Mar 11 2019 - May 22 2023
CASE DETAILS: According to the complaint, defendants made false statements and/or concealed that Integra had failed to take sufficient measures to remediate the violations identified by the FDA in the November 2, 2018 Notice of Inspectional Observations on Form 483 (the “2018 Form 483”), the March 6, 2019 FDA issued warning letter (the “2019 Warning Letter”), and the November 12, 2021 FDA issued Form 483 (the “2021 Form 483”). As a result of those deficiencies, since March 2018, all products manufactured in the Boston Facility had the potential for higher-than-permitted levels of endotoxin and would need to be recalled. Moreover, the Company was not making progress towards obtaining its premarket approval (“PMA”) indication for SurgiMend, in part, because the manufacturing site that would produce the PMA product, the Boston Facility, was in continued violation of the FDA standards that Integra failed to rectify years after the initial notice of the violations and as a result the facility had to be shutdown to correct those ongoing deficiencies.
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