FDA refusal charge
FDA refusal charge FRNMFGREG
Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,…
FRNMFGREG is the FDA import refusal charge for appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,…; it cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 251 refused shipment lines between October 2016 and September 22, 2026, most often for dietary supplements from India.
Data from FDA public records, last checked .
- 251
- refused shipment lines carry this charge
- 39
- countries of origin
- 0
- import alerts name this charge
What FRNMFGREG means
SupplierRadar has not written a plain-English version of FRNMFGREG yet. FDA's own statement is quoted below.
- FD&C Act section
- 502(o)801(a)(3)
- Classification
- misbranding
FDA's official statement
Copied unchanged from FDA's Refusal Charges reference table.
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Countries with the most FRNMFGREG refusals
Shipment lines carrying FRNMFGREG, by country of origin.
| Country | Lines | Share of FRNMFGREG |
|---|---|---|
| India | 61 | 24% |
| China | 27 | 11% |
| Mexico | 14 | 6% |
| South Africa | 13 | 5% |
| Canada | 11 | 4% |
| Colombia | 10 | 4% |
| Germany | 8 | 3% |
| Vietnam | 8 | 3% |
| Syria | 7 | 3% |
| United Kingdom | 6 | 2% |
Product categories with the most FRNMFGREG refusals
| Category | Lines | Share of FRNMFGREG |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 221 | 88% |
| Dietary Conventional Foods and Meal Replacements | 11 | 4% |
| Food Sweeteners (Nutritive) | 8 | 3% |
| Coffee and Tea | 3 | 1% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 3 | 1% |
| Fruit and Fruit Products (vine and other fruits) | 2 | 1% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 1 | 0% |
| Nuts and Edible Seeds | 1 | 0% |
| Soft Drinks and Waters | 1 | 0% |
Latest FRNMFGREG refusals
The 20 most recent refused lines, through September 22, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Karma AyurvedaDelhi, India | Vitamin, n.e.c | NOT LISTEDFRNMFGREG | Source | |
| Laboratorios Vijosa, S.A. de C.V.Antiguo Cuscatlan, El Salvador | Vitamin k (phytonadione) | NOT LISTEDFRNMFGREGUNAPPROVED+1 | Source | |
| Linden-Apotheke M. Spiegel E.K.Graefenhainichen, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| MagnofarmaBogota, Colombia | Vitamin, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Uruz PharmaBogota, D.C., Colombia | Vitamin, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Denova Pharmaceutical SASCajica, Colombia | Vitamin, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Laboratorios Demac LtdaBogota, Colombia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Laboratorios EcarMedellin, Colombia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Uruz PharmaBogota, D.C., Colombia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Laboratorios Demac LtdaBogota, Colombia | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Schuck''''S Cmbh PharmazieSchwaig B. Nurnberg, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTVETDRUGRES+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTVETDRUGRES+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Ocksan Trading Pty Ltd T/A AviomedCape Town, South Africa | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDDIRSEXMPTFRNMFGREG+1 | Source | |
| Aya-HuasscaGUADALAJARA, Mexico | Ginkgo biloba (herbal & botanicals, not teas) | NOT LISTEDFRNMFGREGNO ENGLISH | Source | |
| Laboratorios BoninUnknown, Guatemala | Vitamin b1 (thiamine) | NOT LISTEDFRNMFGREGNO ENGLISH | Source |
Questions about FRNMFGREG
- What does FRNMFGREG mean on an FDA refusal?
- FRNMFGREG is the refusal charge “Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,…”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.”
- What law does FRNMFGREG cite?
- FDA's refusal charge table cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding) for FRNMFGREG, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most FRNMFGREG refusals?
- As of October 26, 2026, the countries with the most FRNMFGREG refusal lines are India (61), China (27) and Mexico (14). The full list with links is in the table on this page.
- Is there an FDA import alert for FRNMFGREG?
- SupplierRadar found no food import alert whose charge section names FRNMFGREG. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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