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.
If you incurred a loss on IART common stock purchased between March 11, 2019 and May 22, 2023, this lawsuit is on your behalf. The lawsuit was filed in the United States District Court for the District of New Jersey, and our firm is reaching out to investors to discuss their legal rights.
If you wish to act as a representative of the shareholders harmed by this misconduct, you may ask the court to appoint you as lead plaintiff. A lead plaintiff directs the litigation and participates in important decisions, including whether to accept a settlement for the class in the action.
You only have until November 13, 2023 to apply to be lead plaintiff. The court will then evaluate the applicants and choose a lead plaintiff. You are not required to act as a lead plaintiff in order to participate in any recovery.
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