What does REFUSE EI mean on an FDA refusal?

REFUSE EI is the refusal charge “Appears to have been manufactured, processed, or packed under insanitary conditions.”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.”

What law does REFUSE EI cite?

FDA's refusal charge table cites section 801(a)(1) of the FD&C Act (insanitary manufacturing, processing or packing) for REFUSE EI, and classifies the charge as insanitary manufacturing, processing or packing. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most REFUSE EI refusals?

As of October 25, 2026, the countries with the most REFUSE EI refusal lines are China (50), South Korea (41) and Brazil (17). The full list with links is in the table on this page.

Is there an FDA import alert for REFUSE EI?

Yes. One FDA import alert names REFUSE EI as a charge code, including Import Alert 99-32 (Foods from foreign establishments refusing FDA inspection). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

FDA refusal charge

FDA refusal charge REFUSE EI

Appears to have been manufactured, processed, or packed under insanitary conditions.

REFUSE EI is the FDA import refusal charge for appears to have been manufactured, processed, or packed under insanitary conditions.; it cites section 801(a)(1) of the FD&C Act (insanitary manufacturing, processing or packing). FDA recorded it on 146 refused shipment lines between October 2016 and September 28, 2026, most often for sauces and prepared meals from China.

Data from FDA public records, last checked October 25, 2026.

146
refused shipment lines carry this charge: 10
countries of origin: 1
import alert names this charge

What REFUSE EI means

SupplierRadar has not written a plain-English version of REFUSE EI yet. FDA's own statement is quoted below.

FD&C Act section: 801(a)(1)
Classification: insanitary manufacturing, processing or packing

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)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

REFUSE EI · 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKINGFDA reference table (CSV)

Import alerts that name REFUSE EI

The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.

Import alerts naming REFUSE EI as a charge
Alert	Covers	Red	Green
99-32	Foods from foreign establishments refusing FDA inspection	96

Countries with the most REFUSE EI refusals

Shipment lines carrying REFUSE EI, by country of origin.

REFUSE EI refusal lines by country
Country	Lines	Share of REFUSE EI
China	50	34%
South Korea	41	28%
Brazil	17	12%
India	15	10%
Japan	6	4%
Oman	5	3%
Taiwan	5	3%
Mexico	4	3%
Poland	2	1%
Italy	1	1%

Product categories with the most REFUSE EI refusals

REFUSE EI refusal lines by product category
Category	Lines	Share of REFUSE EI
Multiple Food Dinners, Gravies, Sauces, and Specialties	27	18%
Candy without Chocolate, Candy Specialties, and Chewing Gum	21	14%
Fishery/Seafood Products	17	12%
Spices, Flavors, and Salts	13	9%
Snack Food Items	11	8%
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties	11	8%
Macaroni and Noodle Products	6	4%
Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)	6	4%
Fruit and Fruit Products (berries, citrus and core fruits)	5	3%
Nuts and Edible Seeds	4	3%

Latest REFUSE EI refusals

The 20 most recent refused lines, through September 28, 2026, each with its FDA source.

Latest FDA refusals carrying REFUSE EI
Date	Firm	Product	Charges
Sep 28, 2026	Bora Foods Pvt LtdPune, India	Sesame seed (edible seed)	REFUSE EI	Source
Sep 23, 2026	Tribal MedicinalJodhpur, India	Herbals & botanicals (not teas), n.e.c	REFUSE EI	Source
Aug 25, 2026	Vitalis Industria de Alimentos LtdaRio de Janeiro, Brazil	Tapioca pudding (pie filling) mix (not custard)	REFUSE EI	Source
Aug 24, 2026	Gipeunsaem Co.,LtdSunchang, South Korea	Pepper, hot, dried or paste	REFUSE EI	Source
Jun 16, 2026	Sitashree Laxminarayn Best ChiwdaPune, India	Snack foods not elsewhere mentioned, n.e.c	REFUSE EI	Source
Jun 12, 2026	Cabio Biotech (Wuhan) Co., LtdWuhan, China	Flavoring agents and adjuvants (food additives for human use)	MFR INSAN REFUSE EI MFR INJ	Source
Jun 9, 2026	Gipeunsaem Co.,LtdSunchang, South Korea	Pepper sauce (hot, mild, etc.)	REFUSE EI	Source
May 20, 2026	Beomchon Fermented FoodsPohang, South Korea	Fish, n.e.c	REFUSE EI 807REFUSAL	Source
May 20, 2026	Beomchon Fermented FoodsPohang, South Korea	Squid, other aquatic species	REFUSE EI 807REFUSAL	Source
May 20, 2026	Beomchon Fermented FoodsPohang, South Korea	Octopus, other aquatic species	REFUSE EI 807REFUSAL	Source
May 20, 2026	Beomchon Fermented FoodsPohang, South Korea	Squid, other aquatic species	REFUSE EI 807REFUSAL	Source
May 20, 2026	Beomchon Fermented FoodsPohang, South Korea	Fish, n.e.c	REFUSE EI 807REFUSAL	Source
May 14, 2026	Sitashree Laxminarayn Best ChiwdaPune, India	Snack foods not elsewhere mentioned, n.e.c	REFUSE EI	Source
May 7, 2026	Dongguan Huayu Food Co., LtdDongguan, China	Salt (table salt) n.e.c	REFUSE EI	Source
May 7, 2026	Dongguan Huayu Food Co., LtdDongguan, China	Pepper, black, ground, cracked (spice)	REFUSE EI	Source
May 7, 2026	Dongguan Huayu Food Co., LtdDongguan, China	Salt (table salt) n.e.c	REFUSE EI	Source
May 7, 2026	Dongguan Huayu Food Co., LtdDongguan, China	Pepper, black, ground, cracked (spice)	REFUSE EI	Source
Apr 28, 2026	All in One TradingMuscat, Oman	Saffron, whole (spice)	REFUSE EI	Source
Apr 28, 2026	All in One TradingMuscat, Oman	Saffron, whole (spice)	REFUSE EI	Source
Apr 20, 2026	Ivenet Gyeongpo FoodGangreung, South Korea	Mixed starch snacks, baked	REFUSE EI	Source

Questions about REFUSE EI

What does REFUSE EI mean on an FDA refusal?: REFUSE EI is the refusal charge “Appears to have been manufactured, processed, or packed under insanitary conditions.”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.”
What law does REFUSE EI cite?: FDA's refusal charge table cites section 801(a)(1) of the FD&C Act (insanitary manufacturing, processing or packing) for REFUSE EI, and classifies the charge as insanitary manufacturing, processing or packing. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most REFUSE EI refusals?: As of October 25, 2026, the countries with the most REFUSE EI refusal lines are China (50), South Korea (41) and Brazil (17). The full list with links is in the table on this page.
Is there an FDA import alert for REFUSE EI?: Yes. One FDA import alert names REFUSE EI as a charge code, including Import Alert 99-32 (Foods from foreign establishments refusing FDA inspection). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.