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FDA Warning Letter Explorer
FDA warning letter · Drugs

The Body Bean, LLC

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

you are manufacturing a hand sanitizer for U.S. commercial distribution for which you have not registered your establishment and listed your drug product with the FDA.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 207.17(a)
  • 21 CFR 207.41(a)