Importadora y Manufacturera Burluart S.A.

4 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED4 refused lines

  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.

• 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.

Questions about Importadora y Manufacturera Burluart S.A.

Is Importadora y Manufacturera Burluart S.A. on an FDA import alert?

No listing for Importadora y Manufacturera Burluart S.A. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Mexico page.

Has FDA refused shipments from Importadora y Manufacturera Burluart S.A.?

Yes. FDA refused 4 shipment lines from Importadora y Manufacturera Burluart S.A. between April 1, 2025 and August 25, 2026. The most recent, on August 25, 2026, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Importadora y Manufacturera Burluart S.A.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 4 lines) and NO ENGLISH (required label information not in english, 1 line).

What is Importadora y Manufacturera Burluart S.A.'s FEI number?

Importadora y Manufacturera Burluart S.A.'s FDA Establishment Identifier (FEI) is 3003723705.