Gelpharma S.A. de C.V.

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

Refusal charges, in plain English

• UNAPPROVED10 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 ENGLISH6 refused lines

  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 Gelpharma S.A. de C.V.

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

No listing for Gelpharma 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 Gelpharma S.A. de C.V.?

Yes. FDA refused 10 shipment lines from Gelpharma S.A. de C.V. between December 9, 2020 and April 15, 2026. The most recent, on April 15, 2026, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

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

The most frequent charges are UNAPPROVED (unapproved new drug, 10 lines) and NO ENGLISH (required label information not in english, 6 lines).

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

FDA's most recent inspection of Gelpharma S.A. de C.V. with a final classification is dated October 8, 2014 and was classified VAI (Voluntary Action Indicated).

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

Gelpharma S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3010158287.