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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

AseptiKits, 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

Your website includes a statement under “Key Differentiators” that your products “*Meets or exceeds FDA regulations*.” Because the subject devices lack required authorization, these representations are false and misleading and a device is misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), if its labeling is false or misleading in any particular.

Citations in the original letter

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

  • 21 CFR 880.5440(b)
  • 21 CFR 880.5440(a)