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FDA Warning Letter Explorer
FDA warning letter · Drugs

MedisourceRx

Issued · Posted by FDA

FDA published a close-out letter on Jul 30, 2026. 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

You failed to submit the adverse event report identified in Complaint Log # C25004.

Passage 2

Failure to Report Adverse Events

Citations in the original letter

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

  • 21 CFR 201.115
  • 21 CFR 310.305(b)
  • 21 CFR 310.305