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FDA Warning Letter Explorer
FDA warning letter · Biologics

Infinant Health, Inc formerly Evolve Biosystems Inc.

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 product is not the subject of an approved BLA nor is there an IND in effect for its use. Based on this information, your actions have violated the FD&C Act and the PHS Act.

Passage 2

your Evivo with MCT Oil product is an adulterated food under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)], because when intended for consumption by preterm infants, this use of *B. longum* subsp. *infantis* “EVC001” is an unsafe food additive within the meaning of sections 201(s) and 409(a) of the FD&C Act.

Citations in the original letter

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

  • 21 CFR 170.30
  • 21 CFR 312