BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Melanie M. Hoppers, M.D./Physicians Quality Care

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. Examples of this failure include, but are not limited to, the following:

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