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FDA Warning Letter Explorer
FDA warning letter · Drugs

CytoDyn, Inc.

Issued · Posted by FDA

FDA published a close-out letter on Jul 25, 2023. The passages below are from the original warning letter.

Selected passages from the FDA letter

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

Passage 1

Failure to adequately address this matter may lead to regulatory action. If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.

Citations in the original letter

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

  • 21 CFR 201.5
  • 21 CFR 201.115(b)
  • 21 CFR 201.100
  • 21 CFR 312.7(a)