Gokce Bitkisel Urunler-Ufuk Gokce

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

Refusal charges, in plain English

• UNAPPROVED9 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.

• 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.

• 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.

• 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.

• FALSE1 refused line

  False or misleading labeling

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

• 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.

Questions about Gokce Bitkisel Urunler-Ufuk Gokce

Is Gokce Bitkisel Urunler-Ufuk Gokce on an FDA import alert?

Yes. As of October 26, 2026, Gokce Bitkisel Urunler-Ufuk Gokce is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for secret miracle honey; leopard miracle honey; vitamins/minerals (human/animal); proteins/unconv dietary supp (human); FDA published the listing on January 16, 2019.

Has FDA refused shipments from Gokce Bitkisel Urunler-Ufuk Gokce?

Yes. FDA refused 10 shipment lines from Gokce Bitkisel Urunler-Ufuk Gokce between February 26, 2019 and September 29, 2021. The most recent, on September 29, 2021, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Gokce Bitkisel Urunler-Ufuk Gokce's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 9 lines) and NCONTACT (no u.s. adverse event contact on supplement label, 2 lines).

What is Gokce Bitkisel Urunler-Ufuk Gokce's FEI number?

Gokce Bitkisel Urunler-Ufuk Gokce's FDA Establishment Identifier (FEI) is 3014814805.

Can shipments from Gokce Bitkisel Urunler-Ufuk Gokce still enter the U.S.?

Shipments of secret miracle honey; leopard miracle honey; vitamins/minerals (human/animal); proteins/unconv dietary supp (human) from Gokce Bitkisel Urunler-Ufuk Gokce can be detained without physical examination under Import Alert 54-16; 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).