Marudhar Impex

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

Refusal charges, in plain English

• UNAPPROVED41 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.

• SUPPL GMP16 refused lines

  Dietary supplement CGMP not met

  The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.

• NUTRIT LBL12 refused lines

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• DIETARYLBL10 refused lines

  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).

• LACKS FIRM8 refused lines

  Manufacturer name and address missing

  The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.

• BIO TOXIN6 refused lines

  BIO TOXIN

• FILTHY5 refused lines

  Filthy, putrid or decomposed substance

  The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.

• NCONTACT5 refused lines

  No U.S. adverse event contact on supplement label

  The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

Questions about Marudhar Impex

Is Marudhar Impex on an FDA import alert?

Yes. As of October 25, 2026, Marudhar Impex is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for berberine capsules; apple cider vinegar powder; jamun seed powder; miniature papaya leaf powder; papaya leaf powder/aloe vera powder/cascara sagrada extract capsules; papaya leaf powder; soursop capsules; sea moss capsules; fenugreek organic powder; lemongrass organic powder; asafoetida powder; bla…; FDA published the listing on August 21, 2024.

Has FDA refused shipments from Marudhar Impex?

Yes. FDA refused 94 shipment lines from Marudhar Impex between July 6, 2017 and September 5, 2025. The most recent, on September 5, 2025, was dietary conventional foods, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Marudhar Impex's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 41 lines) and SUPPL GMP (dietary supplement cgmp not met, 16 lines).

When was Marudhar Impex last inspected by FDA?

FDA's most recent inspection of Marudhar Impex with a final classification is dated November 1, 2023 and was classified OAI (Official Action Indicated).

What is Marudhar Impex's FEI number?

Marudhar Impex's FDA Establishment Identifier (FEI) is 3012291348.

Can shipments from Marudhar Impex still enter the U.S.?

Shipments of berberine capsules; apple cider vinegar powder; jamun seed powder; miniature papaya leaf powder; papaya leaf powder/aloe vera powder/cascara sagrada extract capsules; papaya leaf powder; soursop capsules; sea moss capsules; fenugreek organic powder; lemongrass organic powder; asafoetida powder; bla… from Marudhar Impex can be detained without physical examination under Import Alert 99-39; 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).