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FDA Warning Letter Explorer
FDA warning letter · Drugs

Samm Solutions, Inc., d.b.a. BTS Research

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

Failure to ensure that all raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study raises concerns about the integrity of study records and data.

Citations in the original letter

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

  • 21 CFR 58
  • 21 CFR 58.33(b)
  • 21 CFR 58.81
  • 21 CFR 58.185
  • 21 CFR 58.35
  • 21 CFR 58.33(f)