Industria Farmaceutica, S.A.

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

Refusal charges, in plain English

• UNAPPROVED2 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.

• HEALTH C1 refused line

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LABELING1 refused line

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

• 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 Industria Farmaceutica, S.A.

Is Industria Farmaceutica, S.A. on an FDA import alert?

No listing for Industria Farmaceutica, 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 Guatemala page.

Has FDA refused shipments from Industria Farmaceutica, S.A.?

Yes. FDA refused 3 shipment lines from Industria Farmaceutica, S.A. between June 4, 2025 and February 10, 2026. The most recent, on February 10, 2026, was vitamin e (tocopherol), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Industria Farmaceutica, S.A.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 2 lines) and HEALTH C (unauthorized nutrient content or health claim, 1 line).

What is Industria Farmaceutica, S.A.'s FEI number?

Industria Farmaceutica, S.A.'s FDA Establishment Identifier (FEI) is 3004579170.