FDA refusal charge
FDA refusal charge ALRGN402A4
It appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was…
ALRGN402A4 is the FDA import refusal charge for it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was…; it cites section 801(a)(3) of the FD&C Act (402(a)4). FDA recorded it on 31 refused shipment lines between October 2016 and November 18, 2025, most often for bakery products from Taiwan.
Data from FDA public records, last checked .
- 31
- refused shipment lines carry this charge
- 11
- countries of origin
- 1
- import alert names this charge
What ALRGN402A4 means
SupplierRadar has not written a plain-English version of ALRGN402A4 yet. FDA's own statement is quoted below.
- FD&C Act section
- 801(a)(3)
- Classification
- 402(a)4
FDA's official statement
Copied unchanged from FDA's Refusal Charges reference table.
it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact.
Import alerts that name ALRGN402A4
The charge section of each alert names this code. An alert lists firms; a charge is the reason recorded on one refused line.
| Alert | Covers | Red | Green |
|---|---|---|---|
| 99-22 | Undeclared or mislabeled major food allergens | 121 |
Countries with the most ALRGN402A4 refusals
Shipment lines carrying ALRGN402A4, by country of origin.
| Country | Lines | Share of ALRGN402A4 |
|---|---|---|
| Taiwan | 7 | 23% |
| South Korea | 5 | 16% |
| Poland | 4 | 13% |
| Bangladesh | 3 | 10% |
| Ireland | 3 | 10% |
| Russia | 3 | 10% |
| Jordan | 2 | 6% |
| China | 1 | 3% |
| Guatemala | 1 | 3% |
| India | 1 | 3% |
Product categories with the most ALRGN402A4 refusals
| Category | Lines | Share of ALRGN402A4 |
|---|---|---|
| Bakery Products, Doughs, Bakery Mixes, and Icings | 11 | 35% |
| Vegetable Protein Products (Simulated Meats) | 7 | 23% |
| Chocolate and Cocoa Products | 5 | 16% |
| Macaroni and Noodle Products | 3 | 10% |
| Milk, Butter, and Dried Milk Products | 3 | 10% |
| Fishery/Seafood Products | 1 | 3% |
| Soft Drinks and Waters | 1 | 3% |
Latest ALRGN402A4 refusals
The 20 most recent refused lines, through November 18, 2025, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Nestle India Limited - Moga FactoryAtari, India | Noodles, instant | ALRGN402A4 | Source | |
| Gammoh For Trading CorporationAmman, Jordan | Chocolate candy bar, with nuts or nut products (not coconut) | UNSAFE COLLIST INGRECOLOR LBLG+2 | Source | |
| Gammoh For Trading CorporationAmman, Jordan | Chocolate candy bar, with nuts or nut products (not coconut) | UNSAFE COLLIST INGRECOLOR LBLG+2 | Source | |
| Alimentos Maravilla S.A.Escuintla, Guatemala | Soft drink, citrus fruit flavored, carbonated | JUICE %ALRGN402A4NUTRIT LBL | Source | |
| Banoful & Co.Chittagong, Bangladesh | Zweiback, toast | LIST INGREALLERGENALRGN402A4 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Vegetable protein product, meat textured, with appearance of poultry portions | INCONSPICULACKS N/CALRGN402A4+1 | Source | |
| Butlers Chocolates, UCDublin, Ireland | Chocolate candy bar, without nuts and fruit | ALRGN402A4 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Vegetable protein product, meat textured, with appearance of poultry portions | ALRGN402A4 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Fish-textured vegetable protein (products having appearance of fish portions, fillets, etc.) | LIST INGREINCONSPICUALRGN402A4+1 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Vegetable protein product, meat textured, with appearance of poultry portions | LIST INGREINCONSPICUALRGN402A4+1 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Vegetable protein product, meat textured, with appearance of poultry portions | LIST INGREINCONSPICUALRGN402A4+1 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Fish-textured vegetable protein (products having appearance of fish portions, fillets, etc.) | LIST INGRENO ENGLISHALLERGEN+1 | Source | |
| Kishwan snacks limitedNasirabad, Bangladesh | Plain cookies,biscuits and wafers, n.e.c | LIST INGREFALSELACKS FIRM+3 | Source | |
| Kishwan snacks limitedNasirabad, Bangladesh | Cookie,biscuit,wafer dough, n.e.c | LIST INGRENO ENGLISHALLERGEN+1 | Source | |
| Da Cheng Vegetarian International Co., Ltd.Qionglin Township,, Taiwan | Vegetable protein product, meat textured, with appearance of poultry portions | LIST INGREALLERGENALRGN402A4 | Source | |
| Zhongshan Hongwang Food Co LtdXhongshan City, China | Other bakery products, n.e.c | FALSELACKS FIRMNO ENGLISH+2 | Source | |
| Golden Sea Cold Store and Processing PlantYangon, Myanmar | Carp | LIST INGRELACKS N/CALRGN402A4 | Source | |
| Samyang Foods Co LtdSeoul, South Korea | Noodles, instant | LIST INGREALLERGENALRGN402A4 | Source | |
| Samyang Foods Co LtdSeoul, South Korea | Noodles, instant | LIST INGREFALSENO ENGLISH+3 | Source | |
| Lotte Wellfood Co., Ltd. (Yangsan Factory)Yangsan, South Korea | Mixed plain cookies,biscuits and wafers | LIST INGREALRGN402A4NUTRIT LBL | Source |
Questions about ALRGN402A4
- What does ALRGN402A4 mean on an FDA refusal?
- ALRGN402A4 is the refusal charge “It appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was…”. FDA's official statement for the charge reads: “it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact.”
- What law does ALRGN402A4 cite?
- FDA's refusal charge table cites section 801(a)(3) of the FD&C Act (402(a)4) for ALRGN402A4, and classifies the charge as 402(a)4. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most ALRGN402A4 refusals?
- As of October 25, 2026, the countries with the most ALRGN402A4 refusal lines are Taiwan (7), South Korea (5) and Poland (4). The full list with links is in the table on this page.
- Is there an FDA import alert for ALRGN402A4?
- Yes. One FDA import alert names ALRGN402A4 as a charge code, including Import Alert 99-22 (Undeclared or mislabeled major food allergens). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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