Nisarga Biotech Private Ltd

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

Refusal charges, in plain English

• FALSE3 refused lines

  False or misleading labeling

  The labeling appeared to be false or misleading in some particular.

• LABELING2 refused lines

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

• NUTRIT LBL2 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.

• POISONOUS2 refused lines

  Poisonous or deleterious substance

  The product appeared to bear or contain a poisonous or deleterious substance which may render it injurious to health.

• UNSAFE ADD2 refused lines

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

• HEALTH C1 refused line

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LACKS FIRM1 refused line

  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.

• LIST INGRE1 refused line

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

Questions about Nisarga Biotech Private Ltd

Is Nisarga Biotech Private Ltd on an FDA import alert?

Yes. As of October 26, 2026, Nisarga Biotech Private Ltd is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for ocimum sanctum extract; FDA published the listing on February 14, 2017.

Has FDA refused shipments from Nisarga Biotech Private Ltd?

Yes. FDA refused 6 shipment lines from Nisarga Biotech Private Ltd between November 21, 2016 and December 5, 2023. The most recent, on December 5, 2023, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as LIST INGRE (ingredients not listed).

Why did FDA refuse Nisarga Biotech Private Ltd's shipments?

The most frequent charges are FALSE (false or misleading labeling, 3 lines) and LABELING (fair packaging and labeling act, 2 lines).

When was Nisarga Biotech Private Ltd last inspected by FDA?

FDA's most recent inspection of Nisarga Biotech Private Ltd with a final classification is dated June 4, 2019 and was classified VAI (Voluntary Action Indicated).

What is Nisarga Biotech Private Ltd's FEI number?

Nisarga Biotech Private Ltd's FDA Establishment Identifier (FEI) is 2000001491.

Can shipments from Nisarga Biotech Private Ltd still enter the U.S.?

Shipments of ocimum sanctum extract from Nisarga Biotech Private Ltd 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).