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FDA Warning Letter Explorer
FDA warning letter · Drugs

Vasyl Melnyk, M.D.

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 retain records required to be maintained under 21 CFR Part 312 for a period of two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is filed or if the application is not approved for such indication, until two years after the investigation is discontinued [21 CFR 312.62(c)].

Passage 2

You failed to adhere to these requirements. Specifically, for Protocol **(b)(4)**, you failed to retain adequate and accurate case histories, including the following:

Citations in the original letter

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

  • 21 CFR 312
  • 21 CFR 312.62(c)