Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.

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

Refusal charges, in plain English

• UNAPPROVED45 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.

• LACKS FIRM4 refused lines

  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.

• NUTRIT LBL3 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.

• HEALTH C2 refused lines

  Unauthorized nutrient content or health claim

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

• 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.

• 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.

• DIRSEXMPT1 refused line

  DIRSEXMPT

• NCONTACT1 refused line

  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.

Questions about Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.

Is Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd. on an FDA import alert?

Yes. As of October 27, 2026, Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd. is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for all honey dietary supplements; FDA published the listing on December 27, 2018.

Has FDA refused shipments from Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.?

Yes. FDA refused 46 shipment lines from Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd. between November 23, 2018 and October 5, 2022. The most recent, on October 5, 2022, 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 Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 45 lines) and LACKS FIRM (manufacturer name and address missing, 4 lines).

What is Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.'s FEI number?

Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd.'s FDA Establishment Identifier (FEI) is 3014753133.

Can shipments from Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd. still enter the U.S.?

Shipments of all honey dietary supplements from Sahe Grup Gida Ilac Kozmetik San. Ve Tic. Ltd. 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).