Broncolin, S.A. de C.V.

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

Refusal charges, in plain English

• UNAPPROVED3 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.

• NUTRIT LBL1 refused line

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

Questions about Broncolin, S.A. de C.V.

Is Broncolin, S.A. de C.V. on an FDA import alert?

No listing for Broncolin, S.A. de C.V. 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 Broncolin, S.A. de C.V.?

Yes. FDA refused 4 shipment lines from Broncolin, S.A. de C.V. between September 19, 2018 and February 2, 2026. The most recent, on February 2, 2026, was foods with supplemental nutrients added, with or without artifical sweetners, charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Broncolin, S.A. de C.V.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 3 lines) and NO ENGLISH (required label information not in english, 1 line).

When was Broncolin, S.A. de C.V. last inspected by FDA?

FDA's most recent inspection of Broncolin, S.A. de C.V. with a final classification is dated November 9, 2012 and was classified VAI (Voluntary Action Indicated).

What is Broncolin, S.A. de C.V.'s FEI number?

Broncolin, S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3009331372.