What does NO PROCESS mean on an FDA import refusal?

NO PROCESS means the manufacturer of a low-acid canned or acidified food appears not to have filed a scheduled process with FDA as 21 CFR Part 108 requires, so FDA treats the product as appearing to be made under insanitary conditions under section 402(a)(4) of the FD&C Act.

What does SALMONELLA mean as an FDA refusal reason?

It means the shipment appeared to contain Salmonella, which FDA's charge statement calls a poisonous and deleterious substance that may render the food injurious to health, under sections 402(a)(1) and 801(a)(3) of the FD&C Act.

What does NEEDS FCE mean?

NEEDS FCE means the manufacturer appears not to be registered with FDA as a low-acid canned food or acidified food manufacturer under 21 CFR 108.25(c)(1) or 108.35(c)(1). That registration is filed on Form FDA 2541, which the regulation calls the food canning establishment registration.

Can one FDA refusal have more than one charge code?

Yes. FDA's import refusal data lists the charge codes for each refused shipment line, and a single line can carry several, for example a pathogen charge together with a labeling charge.

What is the FSVP VIO refusal charge?

FSVP VIO is the charge FDA uses when the importer, as defined in section 805 of the FD&C Act, appears to be in violation of the Foreign Supplier Verification Program requirement; the food can then be refused under section 801(a)(3).

Guide

FDA refusal charge codes explained

Updated October 22, 20269 min read8 primary sources

An FDA refusal charge code is the short label FDA records for the legal reason a shipment was refused, such as SALMONELLA, FILTHY, NO PROCESS or UNSAFE COL; each code maps to an official charge statement and to sections of the FD&C Act, usually section 402 (adulteration) or 403 (misbranding) together with section 801(a)(3), which allows refusal. FDA publishes the full list in its Refusal Charges reference table on the FDA Data Dashboard.

Key facts

Official list: FDA Refusal Charges reference table (ACT_SECTION_CHARGES.CSV)
Most food charges cite: FD&C Act 402 (adulteration) or 403 (misbranding), plus 801(a)(3)
Legal standard: The article appears to violate the law (801(a))
Per refusal: One refused line can carry several charge codes
Same code, different law: Some codes repeat with different sections for foods, drugs, devices or cosmetics

What is an FDA refusal charge code?

When FDA detains or refuses an imported product, the notice lists one or more charges: the legal grounds on which the product appears to violate the Federal Food, Drug, and Cosmetic Act. Each charge has a short code, a fixed charge statement, and the statutory sections it relies on. The FDA Data Dashboard's import refusal records carry these codes in the RefusalCharges field, which FDA describes as the reason codes indicating the charges causing the refusal.

Charge statements use the word appears on purpose. Section 801(a) lets FDA refuse a product that appears violative from the examination of samples or otherwise, so a charge records what the evidence showed at the border, not a court finding.

What do the most common food refusal charge codes mean?

Selected food refusal charges, from FDA's Refusal Charges reference table

Code	What FDA's charge statement says (shortened)	FD&C Act section
SALMONELLA	Appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health	402(a)(1), 801(a)(3)
LISTERIA	Appears to contain Listeria monocytogenes, a poisonous and deleterious substance which may render it injurious to health	402(a)(1), 801(a)(3)
FILTHY	Appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food	402(a)(3), 801(a)(3)
INSANITARY	Appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health	402(a)(4), 801(a)(3)
NO PROCESS	The manufacturer's failure to file a scheduled process shows the product is not made under the mandatory provisions of 21 CFR Part 108	402(a)(4), 801(a)(3)
NEEDS FCE	The manufacturer appears not to be registered as a low-acid canned food or acidified food manufacturer under 21 CFR 108.25(c)(1) or 108.35(c)(1)	402(a)(4), 801(a)(3)
UNSAFE COL	Appears to be, or to bear or contain, a color additive which is unsafe within the meaning of section 721(a)	402(c), 801(a)(3)
COLOR LBLG	Appears to contain an artificial coloring and fails to bear labeling stating that fact	403(k), 801(a)(3)
PESTICIDE	Appears to bear or contain a pesticide chemical residue that adulterates it under section 402(a)(2)(B)	402(a)(2)(B), 801(a)(3)
VETDRUGRES	Appears to contain a new animal drug (or conversion product) that is unsafe within the meaning of section 512	402(a)(2)(C)(ii), 801(a)(3)
UNSAFE ADD	Appears to bear or contain an unsafe food additive within the meaning of section 409	402(a)(2)(C)(i), 801(a)(3)
AFLATOXIN	Appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health	402(a)(1), 801(a)(3)
HISTAMINE	Appears to bear or contain histamine in such quantity as ordinarily renders it injurious to health	402(a)(1), 801(a)(3)
ALLERGEN	The label fails to declare all major food allergens present, as section 403(w)(1) requires	403(w), 801(a)(3)
NUTRIT LBL	The label or labeling fails to bear the required nutrition information	403(q), 801(a)(3)
LIST INGRE	Made from two or more ingredients, and the label fails to bear the common or usual name of each	403(i)(2), 801(a)(3)
NO ENGLISH	Required label information is not prominent and in terms likely to be read and understood, for example missing from one of the label's languages	403(f), 801(a)(3)
LACKS N/C	Packaged food whose label lacks an accurate statement of the quantity of contents	403(e)(2), 801(a)(3)
MFRHACCP	Appears to have been processed in violation of the seafood HACCP rules in 21 CFR 123.6(a) and 123.8(a)	402(a)(4), 801(a)(3)
FSVP VIO	The importer appears to be in violation of section 805, the Foreign Supplier Verification Program requirement	805, 801(a)(3)

Each code has its own page with FDA's full statement and the countries, products and suppliers it has been recorded against: SALMONELLA, LISTERIA, FILTHY, INSANITARY, NO PROCESS, NEEDS FCE, UNSAFE COL, PESTICIDE, VETDRUGRES, ALLERGEN, NUTRIT LBL, LIST INGRE and FSVP VIO.

What is the difference between adulteration and misbranding charges?

Adulteration charges (section 402) are about what is in the food or how it was made: pathogens, filth, pesticide or drug residues, unsafe additives or colors, and insanitary or unregistered processing. Misbranding charges (section 403) are about the label: missing nutrition facts, undeclared allergens, ingredients or colors, English-language requirements and net quantity.

Both lead to refusal through section 801(a)(3). A few charges rely on other paragraphs, such as 801(a)(1) for products that appear to have been manufactured, processed or packed under insanitary conditions (code MFR INSAN), and FSVP VIO relies on section 805, the FSVP requirement for importers.

What does the NO PROCESS refusal charge mean?

NO PROCESS applies to low-acid canned foods and acidified foods. 21 CFR Part 108 requires their manufacturers to file a scheduled process with FDA. When no process is on file for the product, FDA's charge statement says the product is not being made under Part 108 and therefore appears to have been manufactured, processed or packed under insanitary conditions (section 402(a)(4)). The related code NEEDS FCE means the manufacturer appears not to be registered with FDA as a low-acid canned or acidified food manufacturer.

FDA's Import Alert 99-37 covers low-acid canned and acidified foods without filed scheduled processes, and Import Alert 99-36 covers processors that failed to provide process information. RPM 9-8-15 notes that this kind of violation may need a scheduled process filing or registration, rather than clean shipments, before DWPE is removed.

What does a SALMONELLA refusal mean?

The SALMONELLA charge means FDA's evidence showed the product appears to contain Salmonella, which the statute treats as a poisonous and deleterious substance that may make food injurious to health (section 402(a)(1)). Repeat findings can lead to an import alert listing: Import Alert 99-19 covers food products other than those covered by other alerts, and Import Alert 16-81 covers seafood.

What does a FILTHY refusal mean?

FILTHY is the section 402(a)(3) charge: the product appears to consist in whole or in part of a filthy, putrid or decomposed substance, or to be otherwise unfit for food. It is a product-content charge, distinct from INSANITARY, which is about the conditions under which the food was prepared, packed or held.

What does UNSAFE COL mean?

For foods, UNSAFE COL is the section 402(c) charge for a color additive that is unsafe within the meaning of section 721(a), which governs which color additives may be used and how. FDA's Import Alert 45-02 covers foods containing illegal and/or undeclared colors. If the color is permitted but not declared, the labeling charge COLOR LBLG may apply instead.

Where does FDA publish the full list of refusal charge codes?

FDA publishes the Refusal Charges reference table as a CSV file on the FDA Data Dashboard (ACT_SECTION_CHARGES.CSV). Each row gives an identifier, the charge code, the full charge statement and the statutory sections.

Why do refusal charges matter for supplier evaluations?

Under FSVP, the hazards behind a supplier's refusals belong in your evaluation. 21 CFR 1.505(a)(1)(iii)(C) requires you to consider the supplier's food safety history, including results from testing foods for hazards. A pattern of SALMONELLA or PESTICIDE charges points to hazards your verification activities should address, while labeling charges point to label review. See FSVP supplier evaluation: what FDA requires.

Frequently asked questions

What does NO PROCESS mean on an FDA import refusal?: NO PROCESS means the manufacturer of a low-acid canned or acidified food appears not to have filed a scheduled process with FDA as 21 CFR Part 108 requires, so FDA treats the product as appearing to be made under insanitary conditions under section 402(a)(4) of the FD&C Act.
What does SALMONELLA mean as an FDA refusal reason?: It means the shipment appeared to contain Salmonella, which FDA's charge statement calls a poisonous and deleterious substance that may render the food injurious to health, under sections 402(a)(1) and 801(a)(3) of the FD&C Act.
What does NEEDS FCE mean?: NEEDS FCE means the manufacturer appears not to be registered with FDA as a low-acid canned food or acidified food manufacturer under 21 CFR 108.25(c)(1) or 108.35(c)(1). That registration is filed on Form FDA 2541, which the regulation calls the food canning establishment registration.
Can one FDA refusal have more than one charge code?: Yes. FDA's import refusal data lists the charge codes for each refused shipment line, and a single line can carry several, for example a pathogen charge together with a labeling charge.
What is the FSVP VIO refusal charge?: FSVP VIO is the charge FDA uses when the importer, as defined in section 805 of the FD&C Act, appears to be in violation of the Foreign Supplier Verification Program requirement; the food can then be refused under section 801(a)(3).

Sources

Every legal and FDA-process claim above is cited to a primary source. Access dates show when each page was read.

01FDA Data Dashboard: Refusal Charges reference table (ACT_SECTION_CHARGES.CSV)FDA · accessed October 22, 2026
02FDA Data Dashboard API: Import Refusals field definitionsFDA · accessed October 22, 2026
0321 U.S.C. 381, FD&C Act section 801 (Cornell LII)Cornell LII · accessed October 22, 2026
04FDA Import Alerts by number (99-36, 99-37, 16-81, 45-02)FDA · accessed October 22, 2026
05FDA Import Alert 99-19FDA · accessed October 22, 2026
06FDA Regulatory Procedures Manual, Chapter 9 (March 2024)FDA · accessed October 22, 2026
0721 CFR 1.505 (eCFR)eCFR · accessed October 22, 2026
0821 CFR 108.25 (eCFR)eCFR · accessed October 22, 2026

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