FDA 483 - EzriCare, LLC. - March 21, 2023

EzriCare, LLC, an own-label distributor in Lakewood, NJ, was cited for significant deficiencies in its quality control unit and oversight of contract manufacturing organizations (CMOs). The inspection revealed a complete absence of a quality control unit, lack of written procedures for critical quality events, and inadequate controls for product specifications and complaint handling. These issues indicate a severe lack of control over the quality and purity of its distributed sterile and non-sterile OTC drug products.