• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Violation Code Translations

Violation
Code
Section Charge Statement
***   402(a)(5), 801(a)(3); ADULTERATION   The food appears to be, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than be slaughter.  
807REFUSAL   807(b)   The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.  
ADDED BULK   402(b)(4), 801(a)(3); ADULTERATION   The food appears to have a substance added to, mixed or packed with it so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.  
AF-NONRSP   402(a)(4), 801(a)(3);ADULTERATION   The article appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this acidified food pursuant to 21 CFR 108.25 (c)(2) appears to be inadequate to protect the public health.  
AFLATOXIN   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health.  
AGR RX   801(d)(1),(2); IMPORTATION RESTRICTED   The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.  
AGRINSULIN   801(d)(1),(2);IMPORTATION RESTRICTED   The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency  
ALCOHOL   402(d)(2), 801(a)(3); ADULTERATION   The article appears to be a confectionary that bears or contains alcohol in excess of 1/2 of 1% by volume derived solely from the use of flavoring extracts.  
ALLERGEN   403(w) 801(a)(3); Misbranding   the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).  
ALRGN402A4   801(a)(3); 402(a)4; Adulterated   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. [Adulteration, Section 402(a)(4)]  
ANDRO   402(f)(1)(B),801(a)(3);ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury [Adulteration, Section 402(f)(1)(B)  
ANTIBIOTIC   502(l), 801(a)(3); MISBRANDING   The drug appears to purport, or represented as, being composed wholly or partly of an antibiotic and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 507. REPEALED11/97  
BACTERIA   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains  
BANNED   501(g), 801(a)(3); ADULTERATION   The article appears to be a banned device.  
BIO TOXIN   801    
BIO TOXIN   402(a)(1), 801(a)(3), Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain  
BSE DRUGS   501(a)(2)(A), 801(a)(1); Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.  
BSE FILTH   402(a)(3), 801(a)(3); Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be unfit for food.  
BUTTER   402(e), 801(a)(3); ADULTERATION   The article appears to be oleo/margarine or butter with raw materials consisting in whole or in part of a filthy, putrid, or decomposed substance or the article is otherwise be unfit for food.  
CALIBRATED   502(f)(1); 801(a)(3), misbranding   The article is subject to refusal in that it is calibrated in units not commonly used in the United States  
CHLORAMP   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. 348.  
CHOKE HZRD   402(a)(3), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food, because it contains a foreign object which may pose a choking hazard. [Adulteration 402(a)(3)].  
COL ADDED   501(a)(4)(A), 801(a)(3); ADULTERATION   The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).  
COLOR   601%    
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
COLOR LBLG   403(k), 801(a)(3); MISBRANDING   The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.  
CONCEALED   402(b)(3), 801(a)(3); ADULTERATION   It appears to be food which has damage or inferiority concealed in any manner.  
CONTAINER   402(a)(6), 801(a)(3); ADULTERATION   The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.  
CONTAINER   601(d), 801(a)(3); ADULTERATION   The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.  
CONTAINER   501(a)(3), 801(a)(3); ADULTERATION   The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.  
CONTAM CAN   402(a)(1), 801(a)(3); ADULTERATION   The article appears to be held in a container containing a poisonous or deleterious substance which may render it injurious to health.  
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
COSM MISB   602(a) & 801(a)(3); MISBRANDING   The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).  
COSM MISB2   602(a) & 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular [Misbranding, Section 602(a)].  
COSMETIC   601(c), 801(a)(3); Adulteration   The article appears to be an ingredient in a cosmetic product and may have been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.  
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
COUMARIN   402(a)(1), 801(a)(3), Adulteration   The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health.  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
CYCLAMATE   402(a)(2)(C); 801(a)(3)   The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409  
DANGEROUS   502(j), 801(a)(3); MISBRANDING   The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.  
DE IMP GMP   801(a)(1); NON CONFORMING MANUFACTURING PRACTICES   The methods used in, or the facilities or controls used for the manufacture, packing, storage or installation do not conform to the requirements under section 520(f).  
DE/RX KIT   801(d)(1),(2); IMPORTATION RESTRICTED   The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.  
DEVGMPS   520(f); 801(a)(1)   The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).  
DEVICE GMP   501(h), 801(a)(3); ADULTERATION   The methods, facilities, or controls used for the article's manufacture, packing, storage. or installation do not conform with applicable requirements under section 520(f)(1) or a condition prescribed by an order under section 520(f)(2).  
DEVICEGMPS   501(h), 801(a)(1); ADULTERATION   The methods, facilities, or controls used for the article's manufacture, packing, storage, or installation do not conform with applicable requirements under section 520(f)(1) or a condition prescribed by an order under section 520(f)(2).  
DEVNOEXPT   501(i), 801(a)(3)    
DIET INGRE   402(a)(3), 801(a)(3); Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.  
DIETARY   403(j), 801(a)(3); MISBRANDING   The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.  
DIETARYLBL   403(s)(2)(B), 801(a)(3), misbranded   The label/labeling of the dietary supplement fails to identify the product by using the term "dietary supplement".  
DIOXIN   402(a)(1),402(a)(2)(A),402(a)(2)(C)(i),801(a)(3)-Adulterated   The article appears to bear or contain dioxins and/or PCB compounds, poisonous or deleterious substances and/or unapproved food additives which may render it injurious to health.  
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
DIRSEXMPT   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use, and the article does not appear to be exempt from such requirements.  
DISEASED   402(a)(5), 801(a)(3); ADULTERATION   The food appears to be, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.  
DR PACKGNG   502(i) (1), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading  
DR QUALITC   501(c), 801(a)(3); ADULTERATION   The drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.  
DR QUALITY   501(b), 801(a)(3); ADULTERATION   The article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.  
DR QUALITY   501b    
DRG REF EI   801(a)(3), 501(j); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.  
DRUG COLOR   502(m), 801(a)(3); MISBRANDING   The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.  
DRUG GMPS   501(a)(2)(B), 801(a)(3); ADULTERATION   It appears that the methods used in, or the facilities or controls used for, manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices.  
DRUG NAME   502(e)(1); 801(a)(3); Misbranding   The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.  
DULCIN   402(a)(2)(C); 801(a)(3)   The article appears to bear or contain dulcin, an unsafe food additive within the meaning of Section 409  
DV NAME   502(e)(2); 801(a)(3); Misbranding   The article appears to be a device and its labeling fails to bear the proprietary or established name.  
DV QUALITY   501(c); 801(a)(3) Adulteration   The article appears to be a device whose quality falls below that which it purports or is represented to possess.  
E COLI 157   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain E. coli O157:H7 (EHEC), a poisonous and deleterious substance which may render it injurious to health.  
ELTNOCERT   534, 536(a)   It appears that the article is an electronic product subject to a performance standard, and does not have affixed to it a certification in the form of a label or tag in conformity with section 534(h).  
EPHEDALK   801(a)3), 402(f)(1); ADULTERATION   The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.  
EXCESS SUL   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain excessive sulfites, a poisonous and deleterious substance which may render it injurious to health.  
EXPIRED   501(c); 801(a)(3) Adulteration   the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.  
FAILS STD   501(e), 801(a)(3); ADULTERATION   The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.  
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading  
FALSE   403(a)(1), 801(a)(3); MISBRANDING   The labeling appears to be false and misleading in any particular.  
FALSECAT   403(t), 801(a)(3)   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because it purports to be or is represented as catfish but is not a fish classified within the family Ictaluridae.  
FALSERXLBL   503(b)(4)(B), 801(a)(3)   The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&CA in that it appears to be misbranded as defined in section 503(b)(4)(B) of the FD&C Act. The labeling falsely bears the symbol "RX Only".  
FDF4APIGMP   501(a)(2)(B), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:  
FEED & NAD   501(a)(6), 801(a)(3); ADULTERATION   The article appears to be an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512.  
FILTH   601(b), 801(a)(3); ADULTERATION   The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.  
FILTH   501(a)(1)Adulteration   The article is subject to refusal of admission pursuant to section 801(a)(3) of the FFD&CA in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance  
FILTHY   402(a)(3), 801(a)(3); ADULTERATION   The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.  
FLAVR LBLG   403(k), 801(a)(3); MISBRANDING   The article appears to contain an artificial flavoring and it fails to bear labeling stating that fact.  
FLUOROCARB   402(a)(2)(A), 801(a)(3); ADULTERATION   The article appears to contain chloroflurocarbons in violation of 21 CFR 2.125.  
FLUOROCARB   501(a)(5), 801(a)(3); ADULTERATION   The article appears to be a new animal drug containing chloroflurocarbons in violation of 21 CFR 2.125.  
FLUOROCARB   601(a), 801(a)(3); ADULTERATION   The article appears to contain chloroflurocarbons in violation of 21 CFR Part 2.125.  
FORBIDDEN   801(a)(2); FORBIDDEN OR RESTRICTED IN SALE   The article appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.  
FOREIGN OB   402(a)(3), 801(a)(3); ADULTERATION   The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it appears to contain foreign objects.  
FRNMFGREG   502(o), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&CA. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act. [Misbranding, Section 502(o), 801(a)(3)].  
FRNMFGREG   510(i); 801(o)   The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.  
GINSENG   402(a)(2)(C), 801(a)(3); ADULTERATION   The article appears to bear or contain "Ginseng", a food additive which is unsafe within the meaning of Section 409.  
HEALTH C   801(a)(3); 403(r)(1)(A)/(B) misbranding   The article appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.  
HELD INSAN   601(c), 801(a)(3); ADULTERATION   The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.  
HEPATITISA   Section 801(a)(3), 402(a)(1); ADULTERATION   The article appears to contain Hepatitis A Virus, a poisonous or deleterious substance which may render it injurious to health.  
HISTAMINE   402(a)(1), 801(a)(3); Adulteration   The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.  
HOLES   501(c); 801(a)(3) Adulteration   The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.  
IMBED OBJT   402(d)(1), 801(a)(3); ADULTERATION   The article appears to be a confectionary that has partially or completely imbedded therein any nonnutritive object.  
IMITATION   403(c), 801(a)(3); MISBRANDING   The article appears to be an imitation of another food, and the label does not bear in type of uniform size and prominence, the word "imitation" and immediately thereafter, the name of the food imitated.  
IMITN DR   502(i) (2), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be an imitation of another drug. The artice resembles:  
IMPTRHACCP   801(a)(3) , 402(a)(4) Adulteration   The food appears to have been prepared, packed or held under insanitary conditions, or may have become injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12(d).  
INADQ PAST   402(a)(4), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to section 801 (a)(1) in that it appears to have been manufactured or processed under insanitary conditions which may result in unpasteurized or inadequately pasteurized product [Adulteration,402(a)(4)].  
INCONSPICU   403(f), 801(a)(3); MISBRANDING   Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.  
INCONSPICU   502(c), 801(a)(3); MISBRANDING   Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.  
INGRED FIL   402(a)(4), 801(a)(3); Adulteration   The article appears to be an ingredient in a dietary supplement and may have been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.  
INSAN BSE   402(a)(4), 801(a)(3); Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.  
INSANITARY   501(a)(2)(A), 801(a)(3); ADULTERATION   The article appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.  
INSANITARY   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.  
INSULIN   502(k), 801(a)(3); MISBRANDING   The drug appears to purport, or represented as, being composed wholly or partly of insulin and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 506.REPEALED 11/97  
INVDEVICE   501(i), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)  
JUICE %   403(i)(2), 801(a)(3); MISBRANDING   It appears the food is a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.  
JUICEHACCP   801(a)(3);402(a)(4)   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 120 [Adulteration, 402(a)(4)].  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
LACK NOTIF   301(s)   Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).  
LACKS FIRM   403(e)(1), 801(a)(3); MISBRANDING   The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
LACKS N/C   403(e)(2), 801(a)(3); MISBRANDING   The food is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regulations.  
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
LBL STEEL   502(a); 801(a)(3); Misbranding   The labeling for this article appears to be false or misleading: labeling suggests it is composed of stainless steel, but it doesn't meet standard requirements for the appropriate type of stainless steel.  
LBLG ADVER   502(a), 201(n) and 801(a)(3) Misbranding   The art apprs misbranded because its lblg is misledg namely it fails to reveal facts (non-sterility) that are material w/respect to consequences frm the use of the art accordg to lblg or advertisg or undercondtns of customary or usual use  
LEAK/SWELL   402(a)(3), 801(a)(3); ADULTERATION   The article appears to be held in swollen containers or contains micro leaks.  
LENS CERT   502(a), 801(a)(3); MISBRANDING   The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.  
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.  
LISTERIA   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain Listeria, a poisonous and deleterious substance which may render it injurious to health.  
MELAMINE   402(a)(1), 801(a)(3), Adulteration   The article appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C)(i)]  
MELAMINE   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)].  
MELAMINE   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.  
MFR INJ   402(a)(4),801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4) of the Act]  
MFR INSAN   801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING   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.  
MFRHACCP   402(a)(4), 801(a)(3)   The product appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 123.  
N-RX INACT   502(e)(1); 801(a)(3); Misbranding   The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.  
NCONTACTS   403(y), 801(2)(3); Misbranding   The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.  
NEEDS ACID   402(a)(4), 801(a)(3); ADULTERATION   The food appears to have been prepared, packed, or held under insanitary conditions, or it may have been rendered injurious to health due to inadequate acidification.  
NEEDS FCE   402(a)(4), 801(a)(3); ADULTERATION   It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).  
NEW VET DR   501(a)(5), 801(a)(3); ADULTERATION   The article appears to be a new animal drug which is unsafe within the meaning of Section 512(a) in that there is not in effect an approval of an applications filed with respect to its intended use or uses.  
NITROFURAN   402(a)(2)(C)(i), 801(a)(3); Adulteration   The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely nitrofurans, that is unsafe.  
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.  
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
NO EXP DAT   402(g), 801(a)(3); ADULTERATION   The article appears to be a dietary supplement and lacks an expiration date and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practices. regulations, including regulations requiring, when necessary, expiration date labeling.  
NO LICENSE   502(f)(1), 801(a)(3); MISBRANDING & PHS BIOL. ACT 351   The article appears to be a biological product not manufactured at an establishment holding an unsuspended and unrevoked license issued under the Public Health Service Act, Biological Products section 351.  
NO PERMIT   1, 2; PROHIBITION WITHOUT PERMIT   The article of milk or cream is not accompanied by a valid import milk permit, as required by the Federal Import Milk Act (21 U.S.C. 141-149).  
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
NO PMA/PDP   501(f)(1)(A); 801(a)(3); ADULTERATION   The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1). [Adulteration, Section 501(f)(1)(A)]  
NO PROCESS   402(a)(4), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.  
NO REGISTR   536(a); Failure to file initial report   The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).  
NO TAG   536(a),(b); NOT CERTIFIED   It appears that the article does not have affixed to it a certification in the form of a label or tag in conformity with section 534(h).  
NOCONTCODE   402(a)(4), 801(a)(3); ADULTERATION   The low acid or acidified food appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure to mark with a permanent container code pursuant to 21 CFR 113.60(c) or 114.80(b).  
NON STD   536(a),(b); NON STANDARD   It appears that the article fails to comply with applicable standards prescribed under section 534.  
NONCOMELT   534, 536(a)   It appears that the article is an electronic product which fails to comply with one or more applicable standards prescribed under section 534.  
NONNUT SUB   402(d)(3), 801(a)(3); ADULTERATION   The article appears to be confectionery and it bears or contains a nonnutritive substance.  
NONRSP-PRC   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer pursuant to 21 CFR 108.35(c)(2) appears to be inadequate to protect the public health.  
NONRSP-VER   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this thermally processed low acid food packaged in a hermetically sealed container pursuant to 21 CFR 108.35 (c)(2) appears to be inadequate to protect the public health.  
NONSTEEL   502(a) and/or 502(f)(1); Misbranding   Labeling appears false or misleading or fails to bear adequate directions for use,because the article appears to be misrepresented as a disposable single use instrument when it is intended for use as a stainless steel multi-use instrument.  
NOT IMPACT   501(c), 801(a)(3); ADULTERATION   The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
NUTR DEF   412(a)(1), 801(a)(3); Adulterated   the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100  
NUTR UNIT   403(f), 801(a)(3); MISBRANDED   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10 [Misbranded, Section 403(f)].  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.  
OFF ODOR   402(a)(3), 801(a)(3); ADULTERATION   The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food. Contains an off odor.  
OMITTED   402(b)(1), 801(a)(3); ADULTERATION   It appears that a valuable constituent of the article has been in whole or in part omitted or abstraced from the article.  
OPTION ING   403(g)(2), 801(a)(3); MISBRANDING   It appears to be a food for which a definition and standard of identity have been prescribed by regulations under section 401 and appears to not be labelled with the common names of the optional ingredients specified therein.  
OTHER DRUG   502(i) (3), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article is a drug and if it is offered for sale under the name of another drug.  
PATULIN   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain patulin, a poisonous and deleterious substance which may render it injurious to health.  
PB-FOOD   402(a)(1); 801(a)(3); Adulteration   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.  
PERSONALRX   502(a) & (f)(1), 801(a)(3); MISBRANDING   The article appears to be a drug which requires a prescription from your doctor.  
PESTICIDE   402(a)(2)(B), 801(a)(3); ADULTERATION   The article appears to be a raw agricultural commodity that bears or contains a pesticide chemical which is unsafe within the meaning of Section 408(a).  
PESTICIDE2   402(a)(2)(B); 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:  
PESTICIDES   402(a)(2)(B), 802(a)(B); ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:  
POIS CHLOR   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may render it injurious to health.  
POISON PKG   502(p), 801(a)(3); MISBRANDING   The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.  
POISONOUS   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain a poisonous or deleterious substance which may render it injurious to health.  
POISONOUS   601(a), 801(a)(3); ADULTERATION   The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.  
POSS N/STR   501(a)(1); 801(a)(3) ADULTERATION   The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms  
PRESRV LBL   403(k), 801(a)(3); MISBRANDING   The article appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.  
RADIONUC   402(a)(1); 801(a)(3); Adulteration   Article appears to contain the radionuclide, Cesium-137, a poisonous and deleterious substance which may render it injurious to health.  
RECORDS   502(t), 801(a)(3); MISBRANDING   The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.  
REDUCED   501(d)(1), 801(a)(3); ADULTERATION   It appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.  
REFUSE EI   801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING   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.  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
REJECT TEA   1 (21USC41); PROHIBITED TEA   The article is inferior in purity, quality, and fitness for consumption to the standards provided in section 43.TEA ACT REPEALED!  
RX DEVICE   502(a),(f)(1), 801(a)(3); MISBRANDING   The article appears to be a prescription device without a prescription device legend as required by 21 CFR 801.109.  
RX LEGEND   502(a) & (f)(1), 801(a)(3); MISBRANDING   The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).  
RXCOMPOUND   503(b)(4)(A) & 502(c), 801(a)(3); MISBRANDING   the labeling fails to bear, at a minimum, the symbol "Rx only."  
RXLABEL   503(b)(4)(A), 801(a)(3); MISBRANDING   The labeling fails to bear, at a minimum, the symbol "RX Only".  
RXPERSONAL   502(a), 502(f)(1), 801(a)(3), MISBRANDING   The article appears to be a device which requires a prescription from your doctor.  
RXVETLACK   503(f)(4), 801(a)(3)   The article appears to be a drug which requires a prescription from your doctor.  
RXVETLACK2   503(f)(4), 801(a)(3)   The article appears to be a veterinary drug which requires but lacks the "Caution" statement specified at Sec. 503(f)(4).  
SACCHARIN   403(o); 801(a)(3) Misbranded   The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement.  
SACCHARLBL   403(i); 803(a)(3) Misbranding   The article contains Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient  
SACCHARLBL   403(i), 801(a)(3); Misbranding   The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.  
SALMONELLA   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.  
SBGINSENG   801(a)(3); 403(u) Misbranding   The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.  
SHIGELLA   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain Shigella, a poisonous and deleterious substance which may render it injurious to health.  
SOAKED/WET   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health in that it appears to been held in water.  
STAINSTEEL   501(c); 801(a)(3) Adulteration   The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.  
STARANISE   402(a)(2)(C)(i), 801(a)(3), Adulteration   The article appears to bear or contain a food additive, Japanese star anise, that is unsafe within the meaning of section 409.  
STD FILL   403(h)(2), 801(a)(3); MISBRANDING   The article appears to be represented as a food for which a standard of fill of container has been prescribed by regulations as provided by section 401 and it appears it falls below the standard of fill and its label does not so indicate.  
STD IDENT   403(g)(1), 801(a)(3); MISBRANDING   The food appears to be represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 and the food does not appear to conform to such definition and standard.  
STD LABEL   502(s), 801(a)(3); MISBRANDING   The article appears to not bear labeling prescribed by the performance standard established under section 514.  
STD NAME   403(g)(2), 801(a)(3); MISBRANDING   It appears to be a food for which a definition and standard of identity have been prescribed by regulations under section 401 and appears to not be labelled with the name specified in the definition and standard.  
STD QUALIT   403(h)(1), 801(a)(3); MISBRANDING   The article appears to be represented as a food for which a standard of quality has been prescribed by regulation as provided by Sec. 401 and it appears its quality falls below such standard and its label does not so indicate.  
STERILITY   501(a)(2)(A), 801(a)(3); ADULTERATION   The article appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.  
STERILITY   501(a)(1), 801(a)(3); ADULTERATION   The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.  
SUBSTITUTE   402(b)(2), 801(a)(3); ADULTERATION   It appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.  
SUBSTITUTE   501(d)(2), 801(a)(3); ADULTERATION   It appears to be a drug that a substance has been substituted wholly or in part.  
SULFITELBL   403(a)(1), 801(a)(3) ;MISBRANDING   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption [Misbranded, 403(a)(1)], and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient [Misbranded, 403(i)(2)].  
SUPPL GMP   402(g)(1), Adulteration, 801(a)(3), Adulteration   The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.  
TAMPERING   501(a)(2)(B), 801(a)(3); ADULTERATION   It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.  
TISSUE   361   This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.  
TP FLAVOR   902(a)(5), 927(a)(1)(A), 801(a)(3); ADULTERATION   The article is subject ot refusal of admission pursuant to section 801(a)(3) of the Act in that it purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 907, and the article (or its components) appears to contain, as a constituent or additive, an artificial or natural flavor or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke.  
TP NO PMTA   801(a)(3);902(6)(A);ADULTERATION   This article is subject to refusal of admission pursuant to section 801(a)(3)of the Act because it is a tobacco product that appears to be adulterated under section 902(6)(A) in that it requires premarket review under section 910(a) and does not have an order in effect under section 910(c)(1)(A)(i). [Adulteration: Section 902(6)(A) FD&C Act]  
TP NO SE   801(a)(3);903(a)(6);MISBRANDING   This article is subject to refusal of admission pursuant to section 801(a)(3) of the Act because it is a tobacco product which appears to be misbranded under section 903(a)(6)in that a notice or other information respecting it was not provided as required by section 905(j). [Misbranding: Section 903(a)(6)FD&C Act]  
TP VIOL911   902(8); 801(a)(3), Adulteration   The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a tobacco product in violation of section 911 of the Act. [Adulteration: Section 902(8)]  
TPLBLFALSE   903(a)(1);801(a)(3);MISBRANDING   This article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it is a smokeless tobacco product and it appears that its labeling is false or misleading because its package does not bear any of the warnings required by section 3 of the Comprehensive Smokeless Tobacco Education Act, as amended (i.e., it does not bear any of the following warnings: "WARNING: This product can cause mouth cancer." "WARNING: This product can cause gum disease and tooth loss." "WARNING: This product is not a safe alternative to cigarettes." "WARNING: Smokeless tobacco is addictive.")  
TPNOWRNLBL   903(a)(8)(B)(i);801(a)(3);MISBRANDING   This article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it is a smokeless tobacco product and it appears that its package label does not include a brief statement of the relevant warnings (i.e., one of the following warnings required by section 3 of the Comprehensive Smokeless Tobacco Education Act as amended: "WARNING: This product can cause mouth cancer." "WARNING: This product can cause gum disease and tooth loss." "WARNING: This product is not a safe alternative to cigarettes." "WARNING: Smokeless tobacco is addictive.")  
TRANSFAT   403(q), 801(a)(3) ;MISBRANDING   The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
UNDER PRC   402(a)(4), 801(a)(3); ADULTERATION   The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.  
UNFIT4FOOD   402(a)(3), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food [Adulteration, 402(a)(3)]  
UNSAFE ADD   402(a)(2)(C)(i), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an unsafe food additive within the meaning of Section 409 [Adulteration, Section 402(a)(2)(C)]. It contains:  
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).  
UNSAFE COL   501(a)(4)(B), 801(a)(3); ADULTERATION   The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).  
UNSAFE SUB   402(a)(2)(A), 801(a)(3); ADULTERATION   The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.  
UNSFDIETLB   402(f)(1)(A), 801(a)(3) Adulteration   The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.  
UNSFDIETSP   402(f)(1)(B), 801(a)(3) Adulteration   The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.  
UNSFDIETUS   402(f)(1)(D), 801(a)(3) Adulteration   The article is or contains a dietary supplement that renders it adulterated under paragraph (a)(1) under conditions of use recommended or suggested in the labeling of such dietary supplement.  
USUAL NAME   403(i)(1), 801(a)(3); MISBRANDING   It appears that the label does not bear the common or usual name of the food.  
VET LEGEND   502(a) & (f)(1), 801(a)(3); MISBRANDING   The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).  
VETDRUGRES   402(a)(2)(C)(ii); 801(a)(3); ADULTERATION   The article appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512. Product contains  
VIBRIO   402(a)(1), 801(a)(3); ADULTERATION   The article appears to contain Vibrio Cholerae, a poisonous and deleterious substance which may render it injurious to health.  
VITAMN LBL   403(a)(2), 801(a)(3); MISBRANDING   The food appears to be subject to section 411 and its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2).  
WARNINGS   502(f)(2), 801(a)(3); MISBRANDING   It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.  
WRONG IDEN   403(b), 801(a)(3); MISBRANDING   The article appears to be offered for sale under the name of another food.  
YELLOW #5   402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING   The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.  
-
-