FDA import refusal charge codes

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Every refusal names one or more FDA charge codes, short labels such as FILTHY or NO PROCESS for the legal reason the entry was refused. Each code below has its own page with FDA's charge language, how often it is cited, and the origins and products it is cited against. Codes cited fewer than 30 times since 2020 have no page.

Safety charges

A refusal citing any of these counts as a hazard finding.

CodeWhat it meansRefusalsGroup
FILTHYfilth4,966Filth and insanitary conditions
PESTICIDEpesticide residue3,895Pesticide residues
UNSAFE COLunsafe color additive3,181Unsafe additives
SALMONELLASalmonella2,387Salmonella
POISONOUSpoisonous or deleterious substance935Contaminants
UNSAFE ADDunsafe food additive841Unsafe additives
MFR INSANinsanitary plant831Filth and insanitary conditions
MFR INJinsanitary handling732Filth and insanitary conditions
MELAMINEmelamine611Contaminants
ALLERGENundeclared allergen508Undeclared allergens
LISTERIAListeria monocytogenes475Listeria monocytogenes
VETDRUGRESveterinary drug residue363Veterinary drug residues
UNSFDIETSPunsafe dietary ingredient356Unsafe additives
INSANITARYinsanitary conditions311Filth and insanitary conditions
UNFIT4FOODunfit for food284Filth and insanitary conditions
POISONORDpoisonous substance267Contaminants
NITROFURANnitrofuran165Veterinary drug residues
HISTAMINEhistamine150Histamine
YELLOW #5FD&C Yellow No. 5 undeclared143Unsafe additives
PB-FOODlead122Contaminants
FOREIGN OBforeign object57Filth and insanitary conditions
REFUSE EIrefused establishment inspection55Filth and insanitary conditions
ADDED BULKbulking agent added51Contaminants
AFLATOXINaflatoxin45Mycotoxins
MYCOTOXINmycotoxin43Mycotoxins
RADIONUCradionuclide41Contaminants
COSM COLORunsafe cosmetic color39Unsafe additives
CYCLAMATEcyclamate37Unsafe additives

Paperwork charges

Counted as paperwork on this site: the charge is about the label, a filing, a registration, an approval or process controls, not a contaminant or pathogen found in the product.

CodeWhat it meansRefusalsGroup
NUTRIT LBLnutrition labeling3,026Labelling
UNAPPROVEDunapproved new drug2,406Process and registration
COLOR LBLGcolor not declared2,139Labelling
NO ENGLISHnot in English2,089Labelling
LIST INGREingredients not listed1,613Labelling
LACKS N/Cno net quantity1,433Labelling
FALSEfalse or misleading label948Labelling
NO PROCESSno process filing934Process and registration
LACKS FIRMno manufacturer name914Labelling
LABELINGlabeling746Labelling
INCONSPICUlabel not conspicuous670Labelling
USUAL NAMEno common name668Labelling
NEEDS FCEno food-canning registration505Process and registration
FSVP VIOFSVP violation415Process and registration
DIETARYLBLsupplement labeling351Labelling
NCONTACTno contact information286Labelling
NOT LISTEDestablishment not listed204Process and registration
HEALTH Cunauthorized health claim188Labelling
SUPPL GMPsupplement GMP failure165Process and registration
FRNMFGREGforeign plant not registered135Process and registration
STD IDENTnot to standard of identity131Labelling
INADPRCCTLinadequate process control130Process and registration
MFRHACCPHACCP failure108Process and registration
SULFITELBLsulfites not declared107Labelling
COLORLABELcolor additive labeling103Labelling
JUICE %juice percentage not declared100Labelling
DIRSEXMPTno adequate directions88Labelling
DIETARYINGdietary ingredient labeling78Labelling
807REFUSALlisting refusal68Process and registration
PRESRV LBLpreservative not declared60Labelling
FLAVR LBLGflavor not declared54Labelling
STD NAMEno standard name54Labelling
LACK NOTIFno premarket notification51Process and registration
NEEDS ACIDno acidified-food filing49Process and registration
PLANT PARTplant part not declared43Labelling

Other charges

In none of this site's charge groups. A refusal citing one of these and no safety charge is counted with paperwork.

CodeWhat it meansRefusalsGroup
SUBSTITUTEsubstitution41—