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FDA Warning Letter Explorer
FDA warning letter · Drugs

Bertrand P. Cole, D.O.

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 ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Passage 2

You failed to adhere to this requirement for four out of four enrolled subjects over multiple study visits. Specifically:

Citations in the original letter

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

  • 21 CFR 312.60
  • 21 CFR 312