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FDA Warning Letter Explorer
FDA warning letter · Biologics

Massachusetts Institute of Technology MIT

Issued · Posted by FDA

FDA published a close-out letter on Feb 12, 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

Failure to ensure that information given to subjects as part of informed consent is in accordance with 21 CFR 50.25 [21 CFR § 56.109(b)].

Passage 2

Failure to prepare and maintain adequate documentation of IRB activities [21 CFR 56.115].

Passage 3

Failure to adequately address this matter may lead to regulatory action. Failure to respond to this letter and to take appropriate corrective action could result in FDA taking regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and FDA regulations, please include your reasoning and any supporting information for our consideration.

Citations in the original letter

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

  • 21 CFR 50.25
  • 21 CFR 50.25(a)(4)
  • 21 CFR 50.25(a)(6)
  • 21 CFR 50.25(a)(5)
  • 21 CFR 56.115(a)(2)
  • 21 CFR 56.115(a)(5)
  • 21 CFR 56.109(b)
  • 21 CFR 56.115
  • 21 CFR 56.115(a)