Dabur India Limited, Sahibabad Unit

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

Refusal charges, in plain English

• NO ENGLISH2 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.

• 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.

• USUAL NAME2 refused lines

  Common or usual name missing

  The label appeared not to show the common or usual name of the food.

Questions about Dabur India Limited, Sahibabad Unit

Is Dabur India Limited, Sahibabad Unit on an FDA import alert?

Yes. As of October 26, 2026, Dabur India Limited, Sahibabad Unit is on the red list of FDA Import Alert 99-08, “Processed human and animal foods: pesticides”, for triphala; FDA published the listing on September 16, 2009.

Has FDA refused shipments from Dabur India Limited, Sahibabad Unit?

Yes. FDA refused 4 shipment lines from Dabur India Limited, Sahibabad Unit between September 4, 2019 and October 15, 2021. The most recent, on October 15, 2021, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Dabur India Limited, Sahibabad Unit's shipments?

The most frequent charges are NO ENGLISH (required label information not in english, 2 lines) and UNAPPROVED (unapproved new drug, 2 lines).

When was Dabur India Limited, Sahibabad Unit last inspected by FDA?

FDA's most recent inspection of Dabur India Limited, Sahibabad Unit with a final classification is dated July 15, 2016 and was classified VAI (Voluntary Action Indicated).

What is Dabur India Limited, Sahibabad Unit's FEI number?

Dabur India Limited, Sahibabad Unit's FDA Establishment Identifier (FEI) is 3004326829.

Can shipments from Dabur India Limited, Sahibabad Unit still enter the U.S.?

Shipments of triphala from Dabur India Limited, Sahibabad Unit can be detained without physical examination under Import Alert 99-08; 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).