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The Body Bean, LLC failed to register its establishment and list its hand sanitizer product (The Body Bean's Hand Sanitizer - Scented) with the FDA as required under section 510 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 207. The company had previously received an FDA notice on October 21, 2022 regarding these same registration and listing violations but failed to correct the deficiencies. This failure to register and list rendered the hand sanitizer misbranded and constituted a prohibited act under the FD&C Act.