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Similasan AG was cited for manufacturing and distributing unapproved new drug ophthalmic products (including Dry Eye Relief, Pink Eye Relief, and Allergy Eye Relief formulations) in violation of federal law, as well as for significant Current Good Manufacturing Practice (CGMP) violations in their manufacturing facility in Jonen, Switzerland. The FDA inspection conducted in March-April 2023 identified deficiencies in the company's methods, facilities, and controls for manufacturing, processing, and holding drug products, rendering these products adulterated. The company's website directed U.S. consumers to purchase these unapproved drugs through linked retail sites, constituting unauthorized introduction of new drugs into interstate commerce.