FDA WARNING_LETTER - The Body Bean, LLC - February 07, 2023

On February 6, 2023, the FDA issued Warning Letter WL 2474 to The Body Bean, LLC, for failing to register their establishment and list their drug product, "The Body Bean’s Hand Sanitizer - Scented," with the FDA. This violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was previously communicated to the firm on October 21, 2022, but no corrective action was taken.

The FDA cited violations of Section 510(j) of the FD&C Act and 21 CFR Part 207.17(a) and 21 CFR 207.41(a), which mandate establishment registration for drug manufacturers and listing of all commercially distributed drugs. The firm's failure to register and list is prohibited under Section 301(p) of the FD&C Act (21 U.S.C. 360 and 331(p)). Additionally, the unlisted drug is considered misbranded under Section 502(o) of the FD&C Act (21 U.S.C. 352(o)), a violation of Section 301(a) (21 U.S.C. 331(a)).

The FDA emphasized that accurate registration and listing are crucial for patient safety, drug establishment