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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