Quantum Naturals India Private Limited

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

Refusal charges, in plain English

• NCONTACT8 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.

• NUTRIT LBL8 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.

• COLOR LBLG5 refused lines

  Artificial coloring not declared

  The product appeared to contain an artificial coloring without labeling that states that fact.

• UNAPPROVED4 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.

• UNSAFE COL3 refused lines

  Color additive unsafe under section 721

  The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

Questions about Quantum Naturals India Private Limited

Is Quantum Naturals India Private Limited on an FDA import alert?

Yes. As of October 26, 2026, Quantum Naturals India Private Limited is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for zenrex capsules herbal supplement; zenfem capsules herbal supplement; FDA published the listing on January 24, 2017.

Has FDA refused shipments from Quantum Naturals India Private Limited?

Yes. FDA refused 8 shipment lines from Quantum Naturals India Private Limited on April 13, 2017. The most recent, on April 13, 2017, was herbals & botanicals (not teas), n.e.c., charged as COLOR LBLG (artificial coloring not declared).

Why did FDA refuse Quantum Naturals India Private Limited's shipments?

The most frequent charges are NCONTACT (no u.s. adverse event contact on supplement label, 8 lines) and NUTRIT LBL (nutrition information missing from label, 8 lines).

What is Quantum Naturals India Private Limited's FEI number?

Quantum Naturals India Private Limited's FDA Establishment Identifier (FEI) is 3013114420.

Can shipments from Quantum Naturals India Private Limited still enter the U.S.?

Shipments of zenrex capsules herbal supplement; zenfem capsules herbal supplement from Quantum Naturals India Private Limited can be detained without physical examination under Import Alert 45-02; 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).