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FDA Warning Letter Explorer
FDA warning letter · Drugs

Kevin R. Bender, M.D./DBC Research Corporation

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

You failed to take adequate precautions to prevent theft or diversion of an investigational drug that is subject to the Controlled Substances Act [21 CFR 312.69], and you failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Citations in the original letter

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

  • 21 CFR 312.69
  • 21 CFR 312.60
  • 21 CFR 312