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FDA Warning Letter Explorer
FDA warning letter · Biologics

Amy Lightner, MD

Issued · Posted by FDA

FDA published a close-out letter on Jun 3, 2025. 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 ensure that an investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations. 21 CFR § 312.60.

Passage 2

You failed to retain records and reports as required for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified 21 CFR § 312.57(c).

Citations in the original letter

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

  • 21 CFR 312.50
  • 21 CFR 312.57(c)
  • 21 CFR 312.60
  • 21 CFR 312