NuEra Nutraceutical Inc

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

Refusal charges, in plain English

• SUPPL GMP11 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.

• NCONTACT2 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.

• 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.

• DIETARYLBL1 refused line

  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).

• NUTRIT LBL1 refused line

  Nutrition information missing from label

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

Questions about NuEra Nutraceutical Inc

Is NuEra Nutraceutical Inc on an FDA import alert?

Yes. As of October 26, 2026, NuEra Nutraceutical Inc is on the red list of FDA Import Alert 54-14, “Supplements from firms not meeting supplement GMP”, for whole grains/milled grain products/starches; bakery products/dough/mixes/icings; macaroni/noodle products; cereal preparations/breakfast foods; snack food items; milk/butter/dried milk products; cheese/cheese products; ice cream and related products; filled milk/imitation milk products; eggs/egg pr…; FDA published the listing on June 21, 2022.

Has FDA refused shipments from NuEra Nutraceutical Inc?

Yes. FDA refused 13 shipment lines from NuEra Nutraceutical Inc between August 3, 2017 and December 5, 2025. The most recent, on December 5, 2025, was vitamin b2 (riboflavin), charged as SUPPL GMP (dietary supplement cgmp not met).

Why did FDA refuse NuEra Nutraceutical Inc's shipments?

The most frequent charges are SUPPL GMP (dietary supplement cgmp not met, 11 lines) and NCONTACT (no u.s. adverse event contact on supplement label, 2 lines).

When was NuEra Nutraceutical Inc last inspected by FDA?

FDA's most recent inspection of NuEra Nutraceutical Inc with a final classification is dated February 18, 2022 and was classified OAI (Official Action Indicated).

What is NuEra Nutraceutical Inc's FEI number?

NuEra Nutraceutical Inc's FDA Establishment Identifier (FEI) is 3008240184.

Can shipments from NuEra Nutraceutical Inc still enter the U.S.?

Shipments of whole grains/milled grain products/starches; bakery products/dough/mixes/icings; macaroni/noodle products; cereal preparations/breakfast foods; snack food items; milk/butter/dried milk products; cheese/cheese products; ice cream and related products; filled milk/imitation milk products; eggs/egg pr… from NuEra Nutraceutical Inc can be detained without physical examination under Import Alert 54-14; 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).