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Scope Health Inc was cited for marketing seven ophthalmic drug products (including MGD Advanced Dry Eye Drops, Dry Eye Intense Drops, Allegro Eye Drops, HYLO Night Eye Ointment, and tea tree oil-based products) as unapproved new drugs in violation of section 505(a) of the FD&C Act, since they lacked FDA approval despite being sold over-the-counter on the company's website. Additionally, five of these products were found to be misbranded under sections 502(f)(2) and 502(ee) of the FD&C Act, failing to meet labeling requirements for new drugs. The FDA inspection of the company's labeling and website occurred on August 28, 2024, identifying these violations related to unapproved drug status and inadequate labeling.