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The Richline Group, Inc. manufactured and marketed Inverness Ear Care Antiseptic, Inverness Ear Care Solution, and Inverness Home Ear Piercing Kit without required FDA marketing authorization. The company failed to submit 510(k) premarket review applications for wound wash products containing antimicrobials like benzalkonium chloride, which pose documented risks including adverse tissue reactions, toxicity, delayed wound healing, and antimicrobial resistance. The inspection identified repeat violations from a prior FDA inspection, indicating the company had received previous communications regarding these compliance failures but failed to correct them.