Plantas Herbolarias de Mexico

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.

Questions about Plantas Herbolarias de Mexico

Is Plantas Herbolarias de Mexico on an FDA import alert?

Yes. As of October 26, 2026, Plantas Herbolarias de Mexico is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for vitamins/minerals (human/animal); proteins/unconv dietary supp (human); 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 7, 2023.

Has FDA refused shipments from Plantas Herbolarias de Mexico?

Yes. FDA refused 2 shipment lines from Plantas Herbolarias de Mexico between November 23, 2022 and November 28, 2022. The most recent, on November 28, 2022, 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 Plantas Herbolarias de Mexico's shipments?

The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).

What is Plantas Herbolarias de Mexico's FEI number?

Plantas Herbolarias de Mexico's FDA Establishment Identifier (FEI) is 3024296282.

Can shipments from Plantas Herbolarias de Mexico still enter the U.S.?

Shipments of vitamins/minerals (human/animal); proteins/unconv dietary supp (human); pharm necess & ctnr for drug/bio; antibiotics (human/animal); human and animal therapeutic biologic and biosimilar drugs; human and animal drugs from Plantas Herbolarias de Mexico 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).