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FDA Warning Letter Explorer
FDA warning letter · Biologics

NuVida Medical LLC

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

your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Your products are also unlicensed biological products in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).

Citations in the original letter

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

  • 21 CFR 1271.10(a)
  • 21 CFR 1271
  • 21 CFR 1271.15
  • 21 CFR 1271.10(a)(2)
  • 21 CFR 1271.3(d)
  • 21 CFR 1271.3(c)
  • 21 CFR 1271.4
  • 21 CFR 1271.20