Especialidades Nutrition SA de C

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

Refusal charges, in plain English

• UNAPPROVED13 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 ENGLISH12 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.

• DIETARYLBL1 refused line

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• 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.

• 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.

• UNSAFE ADD1 refused line

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

Questions about Especialidades Nutrition SA de C

Is Especialidades Nutrition SA de C on an FDA import alert?

Yes. As of October 26, 2026, Especialidades Nutrition SA de C is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for umary acido hialuronico; pharm necess & ctnr for drug/bio; antibiotics (human/animal); human and animal therapeutic biologic and biosimilar drugs; human and animal drugs; FDA published the listing on July 29, 2024.

Has FDA refused shipments from Especialidades Nutrition SA de C?

Yes. FDA refused 19 shipment lines from Especialidades Nutrition SA de C between December 21, 2023 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 UNSAFE ADD (food additive unsafe under section 409).

Why did FDA refuse Especialidades Nutrition SA de C's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 13 lines) and NO ENGLISH (required label information not in english, 12 lines).

What is Especialidades Nutrition SA de C's FEI number?

Especialidades Nutrition SA de C's FDA Establishment Identifier (FEI) is 3023330771.

Can shipments from Especialidades Nutrition SA de C still enter the U.S.?

Shipments of umary acido hialuronico; pharm necess & ctnr for drug/bio; antibiotics (human/animal); human and animal therapeutic biologic and biosimilar drugs; human and animal drugs from Especialidades Nutrition SA de C can be detained without physical examination under Import Alert 54-16; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).