Agroherbolaria SA de CV

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

Refusal charges, in plain English

• 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.

• UNAPPROVED1 refused line

  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 Agroherbolaria SA de CV

Is Agroherbolaria SA de CV on an FDA import alert?

Yes. As of October 26, 2026, Agroherbolaria SA de CV is on the red list of FDA Import Alert 99-19, “Food products: Salmonella”, for arnica montana; aloe vera powder; aloe & prickly pear powder; artichoke cynara scolymus; FDA published the listing on August 30, 2011.

Has FDA refused shipments from Agroherbolaria SA de CV?

Yes. FDA refused 1 shipment line from Agroherbolaria SA de CV on March 21, 2024. The most recent, on March 21, 2024, was tea, green, charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Agroherbolaria SA de CV's shipments?

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

What is Agroherbolaria SA de CV's FEI number?

Agroherbolaria SA de CV's FDA Establishment Identifier (FEI) is 3010118557.

Can shipments from Agroherbolaria SA de CV still enter the U.S.?

Shipments of arnica montana; aloe vera powder; aloe & prickly pear powder; artichoke cynara scolymus from Agroherbolaria SA de CV can be detained without physical examination under Import Alert 99-19; 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).