Apothecary products was acquired in february 2014 following which a new management team was established.This included a new regulatory and quality systems team.As part of this transition a regulatory and quality system compliance assessment was conducted, which included a three-year retrospective review of complaints from 1 january 2014 to 31 may 2018 to ensure that reported events that meet the reporting requirements of 21 cfr part 803 medical device reporting (mdr) regulation were notified to the fda.During this review we identified 5 complaints that we believe meet the reporting criteria which were not reported to the fda and are being reported to the fda at this time.New procedures have been implemented to ensure that events that meet the reporting criteria requirements of 21 cfr part 803 are reported to the fda in accordance with regulatory requirements.
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