Synthite Industries Limited

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

Refusal charges, in plain English

• UNSAFE COL2 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.

• FILTHY1 refused line

  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.

• UNSFDIETSP1 refused line

  Dietary ingredient without safety assurance

  The product appeared to be a dietary supplement or dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.

Questions about Synthite Industries Limited

Is Synthite Industries Limited on an FDA import alert?

Yes. As of October 27, 2026, Synthite Industries Limited is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for nat xtra brahmi dietary supplement; nat xtra super ginger dietary supplement; FDA published the listing on May 20, 2025.

Has FDA refused shipments from Synthite Industries Limited?

Yes. FDA refused 4 shipment lines from Synthite Industries Limited between June 30, 2020 and May 2, 2025. The most recent, on May 2, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Synthite Industries Limited's shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 2 lines) and FILTHY (filthy, putrid or decomposed substance, 1 line).

When was Synthite Industries Limited last inspected by FDA?

FDA's most recent inspection of Synthite Industries Limited with a final classification is dated March 13, 2019 and was classified VAI (Voluntary Action Indicated).

What is Synthite Industries Limited's FEI number?

Synthite Industries Limited's FDA Establishment Identifier (FEI) is 3004269765.

Can shipments from Synthite Industries Limited still enter the U.S.?

Shipments of nat xtra brahmi dietary supplement; nat xtra super ginger dietary supplement from Synthite Industries 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).