Farmakom Ltd

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

Refusal charges, in plain English

• DIRSEXMPT1 refused line

  DIRSEXMPT

• UNAPPROVED1 refused line

  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.

Questions about Farmakom Ltd

Is Farmakom Ltd on an FDA import alert?

Yes. As of October 25, 2026, Farmakom Ltd is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for vitamins/minerals (human/animal); proteins/unconv dietary supp (human); male potency-f; FDA published the listing on August 11, 2020.

Has FDA refused shipments from Farmakom Ltd?

Yes. FDA refused 1 shipment line from Farmakom Ltd on August 27, 2020. The most recent, on August 27, 2020, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as DIRSEXMPT (dirsexmpt).

Why did FDA refuse Farmakom Ltd's shipments?

The most frequent charges are DIRSEXMPT (dirsexmpt, 1 line) and UNAPPROVED (unapproved new drug, 1 line).

What is Farmakom Ltd's FEI number?

Farmakom Ltd's FDA Establishment Identifier (FEI) is 3008616929.

Can shipments from Farmakom Ltd still enter the U.S.?

Shipments of vitamins/minerals (human/animal); proteins/unconv dietary supp (human); male potency-f from Farmakom 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).