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FDA Warning Letter Explorer
FDA warning letter · Drugs

PolleyMed, 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

Based on our review, your SaniiSwab™ product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Passage 2

your SaniiSwab™ product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your product’s website falsely states that the FDA has approved your product.

Citations in the original letter

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

  • 21 CFR 201.128
  • 21 CFR 207.77(b)