CV Tritop Borneo Kencana

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

Refusal charges, in plain English

• FRNMFGREG2 refused lines

  FRNMFGREG

• NOT LISTED2 refused lines

  Product not listed with FDA

  The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

• 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.

• 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.

Questions about CV Tritop Borneo Kencana

Is CV Tritop Borneo Kencana on an FDA import alert?

Yes. As of October 26, 2026, CV Tritop Borneo Kencana is on the red list of FDA Import Alert 99-45, “Foods that are or contain an unsafe food additive”, for kratom e-liquid moonlight; kratom e-liquid sunrise; FDA published the listing on January 29, 2024.

Has FDA refused shipments from CV Tritop Borneo Kencana?

Yes. FDA refused 4 shipment lines from CV Tritop Borneo Kencana on February 16, 2024. The most recent, on February 16, 2024, was kratom (herbal and botanicals, not teas ii), charged as UNSAFE ADD (food additive unsafe under section 409).

Why did FDA refuse CV Tritop Borneo Kencana's shipments?

The most frequent charges are FRNMFGREG (frnmfgreg, 2 lines) and NOT LISTED (product not listed with fda, 2 lines).

What is CV Tritop Borneo Kencana's FEI number?

CV Tritop Borneo Kencana's FDA Establishment Identifier (FEI) is 3026168951.

Can shipments from CV Tritop Borneo Kencana still enter the U.S.?

Shipments of kratom e-liquid moonlight; kratom e-liquid sunrise from CV Tritop Borneo Kencana can be detained without physical examination under Import Alert 99-45; 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).