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FDA Warning Letter Explorer
FDA warning letter · Biologics

Konrad Rejdak, M.D., Ph.D.

Issued · Posted by FDA

FDA published a close-out letter on Nov 10, 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 prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational product [21 CFR 312.62(b)].

Passage 2

Failure to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations; failure to protect the rights, safety, and welfare of subjects under your care [21 CFR 312.60].

Passage 3

Failure to retain records required to be maintained for a period of 2 years following the date a marketing application is approved. [21 CFR 312.62(c)]

Citations in the original letter

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

  • 21 CFR 312.62(b)
  • 21 CFR 312.60
  • 21 CFR 312.62(c)
  • 21 CFR 50