Sanofi S.P.A.

1 record, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• NO ENGLISH1 refused line

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

• UNAPPROVED1 refused line

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about Sanofi S.P.A.

Is Sanofi S.P.A. on an FDA import alert?

No listing for Sanofi S.P.A. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Italy page.

Has FDA refused shipments from Sanofi S.P.A.?

Yes. FDA refused 1 shipment line from Sanofi S.P.A. on June 11, 2025. The most recent, on June 11, 2025, was mineral n.e.c., charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Sanofi S.P.A.'s shipments?

The most frequent charges are NO ENGLISH (required label information not in english, 1 line) and UNAPPROVED (unapproved new drug, 1 line).

What is Sanofi S.P.A.'s FEI number?

Sanofi S.P.A.'s FDA Establishment Identifier (FEI) is 3037277899.