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Nutritional Laboratories International, Inc. (doing business as Elite One Source Nutritional Services, Inc. and Flawless Beauty and Skin) was cited for importing and distributing medical devices including derma pens, dermastampers, and dermarollers without required FDA approvals or clearances. The company failed to comply with medical device regulations by marketing products intended to treat or affect body structure or function without the necessary premarket authorization, and the products were deemed adulterated under the Federal Food, Drug, and Cosmetic Act. An FDA inspection conducted between November 2021 and January 2022 identified these violations based on evidence from product packaging, labels, user manuals, brochures, and website marketing materials.