FDA refusal charge
FDA refusal charge DRUG GMPS
The methods used in and controls used for the manufacture, processing, packing, or holding of drugs and…
DRUG GMPS is the FDA import refusal charge for the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and…; it cites sections 501(a)(2)(B) and 801(a)(3) of the FD&C Act (adulteration). FDA recorded it on 37 refused shipment lines from 8 countries between October 2016 and August 18, 2026, most often for dietary supplements from India.
Data from FDA public records, last checked .
- 37
- refused shipment lines carry this charge
- 8
- countries of origin
- 0
- import alerts name this charge
What DRUG GMPS means
SupplierRadar has not written a plain-English version of DRUG GMPS yet. FDA's own statement is quoted below.
- FD&C Act section
- 501(a)(2)(B)801(a)(3)
- Classification
- adulteration
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 the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Countries with the most DRUG GMPS refusals
Shipment lines carrying DRUG GMPS, by country of origin.
| Country | Lines | Share of DRUG GMPS |
|---|---|---|
| India | 14 | 38% |
| China | 13 | 35% |
| Canada | 4 | 11% |
| Mexico | 2 | 5% |
| Australia | 1 | 3% |
| Switzerland | 1 | 3% |
| Germany | 1 | 3% |
| South Korea | 1 | 3% |
Product categories with the most DRUG GMPS refusals
| Category | Lines | Share of DRUG GMPS |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 34 | 92% |
| Food Sweeteners (Nutritive) | 2 | 5% |
| Dietary Conventional Foods and Meal Replacements | 1 | 3% |
Latest DRUG GMPS refusals
The 20 most recent refused lines, through August 18, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Hydroxocobalamin (vitamin) | DRUG GMPS | Source | |
| Antaria Pty. Ltd.Rocklea, Australia | Zinc (mineral) | DRUG GMPS | Source | |
| SANUM-Kehlbeck GmbH & Co. KGHoya, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| M/S Jagsonpal Exports India Pvt. Ltd.Delhi, India | Vitamin, n.e.c | DRUG GMPSUNAPPROVED | Source | |
| Similasan AGJonen, Switzerland | Vitamin, n.e.c | DRUG GMPS | Source | |
| Intas Pharmaceuticals LimitedAhmedabad, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| Planet Ayurveda Private LimitedSas Nagar (Mohali), India | Ashwagandha (herbal & botanicals, not teas) | DRUG GMPSSUPPL GMPUNAPPROVED | Source | |
| Les Importations Herbasante Inc.Saint-Laurent, Canada | Dietary conventional foods, n.e.c | DRUG GMPS | Source | |
| Mmc Healthcare Ltd.Chennai, India | Vitamin, n.e.c | DRUG GMPS | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Vitamin b12 (cyanocobalamin) | DRUG GMPS | Source | |
| CMHP Private LimitedAhmedabad, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| Rosy Michael MenezesMumbai, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| CMHP Private LimitedAhmedabad, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| CMHP Private LimitedAhmedabad, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| CMHP Private LimitedAhmedabad, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| CMHP Private LimitedAhmedabad, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DRUG GMPS | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Vitamin b12 (cyanocobalamin) | DRUG GMPS | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Vitamin b12 (cyanocobalamin) | DRUG GMPS | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Mecobalamin (vitamin) | DRUG GMPS | Source | |
| Yuxing Biotechnology (Group) Co., Ltd.Xingtai, China | Mecobalamin (vitamin) | DRUG GMPS | Source |
Questions about DRUG GMPS
- What does DRUG GMPS mean on an FDA refusal?
- DRUG GMPS is the refusal charge “The methods used in and controls used for the manufacture, processing, packing, or holding of drugs and…”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).”
- What law does DRUG GMPS cite?
- FDA's refusal charge table cites sections 501(a)(2)(B) and 801(a)(3) of the FD&C Act (adulteration) for DRUG GMPS, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most DRUG GMPS refusals?
- As of October 26, 2026, the countries with the most DRUG GMPS refusal lines are India (14), China (13) and Canada (4). The full list with links is in the table on this page.
- Is there an FDA import alert for DRUG GMPS?
- SupplierRadar found no food import alert whose charge section names DRUG GMPS. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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