Sanofi Aventis Parmaceutica Ltda

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

Refusal charges, in plain English

• NOT LISTED1 refused line

  Product not listed with FDA

  The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

• 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 Aventis Parmaceutica Ltda

Is Sanofi Aventis Parmaceutica Ltda on an FDA import alert?

No listing for Sanofi Aventis Parmaceutica Ltda appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Brazil page.

Has FDA refused shipments from Sanofi Aventis Parmaceutica Ltda?

Yes. FDA refused 1 shipment line from Sanofi Aventis Parmaceutica Ltda on November 26, 2025. The most recent, on November 26, 2025, was ashwagandha (herbal & botanicals, not teas), charged as NOT LISTED (product not listed with fda).

Why did FDA refuse Sanofi Aventis Parmaceutica Ltda's shipments?

The most frequent charges are NOT LISTED (product not listed with fda, 1 line) and UNAPPROVED (unapproved new drug, 1 line).

What is Sanofi Aventis Parmaceutica Ltda's FEI number?

Sanofi Aventis Parmaceutica Ltda's FDA Establishment Identifier (FEI) is 3006549683.