Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistEpiCare Acquisitions, LLC manufactured the EpiCare-Zenith™ Family of Laser Systems, which are electronic medical devices regulated by the FDA, but failed to comply with Current Good Manufacturing Practice (CGMP) and Quality System Regulation requirements under 21 CFR Part 820. An FDA inspection conducted from November 12 through December 13, 2024, at the company's Lawrenceville, New Jersey facility determined that the devices were adulterated due to deficiencies in the methods, facilities, or controls used during manufacture, packing, storage, or installation. The company submitted a response on January 9, 2025, addressing observations cited on FDA Form 483, though the warning letter indicates multiple unresolved violations related to quality system compliance.