Violation Codes
FDA violation codes ranked by frequency in import refusals
| # | Code | Description | Legal Section | Cases |
|---|---|---|---|---|
| 151 | 3845 DRG REF EI | 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. | 801(a)(3), 501(j); ADULTERATION | 102 |
| 152 | 3580 TP VIOL911 | This article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be in violation of section 911. | 902(8); 801(a)(3), Adulteration | 102 |
| 153 | 2420 RADIONUC | Article appears to contain the radionuclide, Cesium-137, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1); 801(a)(3); Adulteration | 101 |
| 154 | 160 LEAK/SWELL | The article appears to be held in swollen containers or contains micro leaks. | 402(a)(3), 801(a)(3); ADULTERATION | 93 |
| 155 | 299 IMBED OBJT | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a confectionary that has partially or completely imbedded therein any nonnutritive object. | 402(d)(1), 801(a)(3); ADULTERATION | 83 |
| 156 | 55 OMITTED | The article is subject to refusal of admission pursuant Section 801(a)(3) of the FD&C Act in that it appears that a valuable constituent of the article has been in whole or in part omitted or abstracted from the article. | 402(b)(1), 801(a)(3); ADULTERATION | 83 |
| 157 | 280 UNSAFE SUB | The article appears to bear or contain a substance which is unsafe within the meaning of Section 406. | 402(a)(2)(A), 801(a)(3); ADULTERATION | 80 |
| 158 | 3340 DE/RX KIT | 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. | 801(d)(1),(2); IMPORTATION RESTRICTED | 79 |
| 159 | 2960 FALSECAT | 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. | 403(t), 801(a)(3) | 78 |
| 160 | 292 SUBSTITUTE | It appears to be a drug that a substance has been substituted wholly or in part. | 501(d)(2), 801(a)(3); ADULTERATION | 77 |
| 161 | 3896 NOCONTACT | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug. | 502(x),801(a)(3); MISBRANDING | 77 |
| 162 | 3120 EPHEDALK | 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. | 801(a)(3), 402(f)(1)(A); ADULTERATION | 76 |
| 163 | 2940 COSM MISB | The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n). | 602(a) & 801(a)(3); MISBRANDING | 76 |
| 164 | 3161 NONRSP-PRC | 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. | 402(a)(4), 801(a)(3); ADULTERATION | 74 |
| 165 | 152 SOAKED/WET | 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. | 402(a)(4), 801(a)(3); ADULTERATION | 73 |
| 166 | 2461 UNSFDIETUS | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement. | 402(f)(1)(D), 801(a)(3) Adulteration | 70 |
| 167 | 3081 INVDEVICE | 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) | 501(i), 801(a)(3); ADULTERATION | 68 |
| 168 | 2080 COUMARIN | The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health. | 402(a)(1), 801(a)(3), Adulteration | 68 |
| 169 | 3846 807REFUSAL | 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. | 807(b) | 66 |
| 170 | 3902 FALSEDRUG | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading. | 502(a)(1), 801(a)(3); MISBRANDING | 65 |
| 171 | 337 OFF ODOR | 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. | 402(a)(3), 801(a)(3); ADULTERATION | 61 |
| 172 | 2160 LACK NOTIF | 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). | 301(s) | 57 |
| 173 | 3641 CHOKE HZRD | 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. | 402(a)(3), 801(a)(3); ADULTERATION | 54 |
| 174 | 3897 MYCOTOXIN | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous and deleterious substance, namely a mycotoxin (aflatoxin, deoxynivalenol, fumonisin, or ochratoxin A), which may render it injurious to health. Bears or contains: | 402(a)(1), 801(a)(3); ADULTERATION | 54 |
| 175 | 3240 NOCONTCODE | 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). | 402(a)(4), 801(a)(3); ADULTERATION | 53 |
| 176 | 2880 RXCOMPOUND | the labeling fails to bear, at a minimum, the symbol "Rx only." | 503(b)(4)(A) & 502(c), 801(a)(3); MISBRANDING | 51 |
| 177 | 3460 VIBRIO | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Vibrio cholerae, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 49 |
| 178 | 304 STERILITY | The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance. | 501(a)(1), 801(a)(3); ADULTERATION | 48 |
| 179 | 318 VITAMN LBL | 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). | 403(a)(2), 801(a)(3); MISBRANDING | 48 |
| 180 | 3040 HEPATITISA | The article is subject to refusal of admission to pursuant Section 801(a)(3) in that it appears to contain Hepatitis A Virus, a poisonous or deleterious substance which may render it injurious to health. | Section 801(a)(3), 402(a)(1); ADULTERATION | 48 |
| 181 | 3701 ALRGN402A4 | 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. | 801(a)(3); 402(a)4; Adulterated | 47 |
| 182 | 3362 NUTR UNIT | 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. | 403(f), 801(a)(3); MISBRANDED | 46 |
| 183 | 3060 POIS CHLOR | The article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 45 |
| 184 | 3361 NUTR DEF | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100 | 412(a)(1), 801(a)(3); Adulterated | 45 |
| 185 | 199 FEED & NAD | 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. | 501(a)(6), 801(a)(3); ADULTERATION | 45 |
| 186 | 288 STD LABEL | The article appears to not bear labeling prescribed by the performance standard established under section 514. | 502(s), 801(a)(3); MISBRANDING | 45 |
| 187 | 73 DRUG COLOR | 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. | 502(m), 801(a)(3); MISBRANDING | 44 |
| 188 | 3885 POIS CHLOR | The article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 44 |
| 189 | 3847 FDF4APIGMP | 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: | 501(a)(2)(B), 801(a)(3); ADULTERATION | 43 |
| 190 | 3480 E COLI 157 | The article appears to contain E. coli O157:H7 (EHEC), a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 43 |
| 191 | 3761 FILTH | The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act 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 | 501(a)(1)Adulteration | 35 |
| 192 | 3160 NONRSP-VER | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product 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. | 402(a)(4), 801(a)(3); ADULTERATION | 35 |
| 193 | 343 VET LEGEND | The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4). | 502(a) & (f)(1), 801(a)(3); MISBRANDING | 34 |
| 194 | 302 BUTTER | 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. | 402(e), 801(a)(3); ADULTERATION | 32 |
| 195 | 226 DEVICE GMP | The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act. | 501(h), 801(a)(3); ADULTERATION | 30 |
| 196 | 3860 TP USERFEE | This article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that the tobacco product appears to be adulterated under Section 902(4) because the importer of the tobacco product failed to pay a user fee assessed to such importer pursuant to Section 919 by the date specified in Section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of the fee. | 902(4);801(a)(3); ADULTERATION | 28 |
| 197 | 469 DISEASED | 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. | 402(a)(5), 801(a)(3); ADULTERATION | 28 |
| 198 | 255 STD FILL | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(h)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations as provided by Section 401 of the FD&C Act and the article falls below the applicable standard of fill and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify. | 403(h)(2), 801(a)(3); MISBRANDING | 28 |
| 199 | 2060 AGRINSULIN | 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 | 801(d)(1),(2);IMPORTATION RESTRICTED | 28 |
| 200 | 3900 NDIDIETSP | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food that is a dietary supplement or that contains a dietary ingredient that is 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. | 402(f)(1)(B), 801(a)(3) Adulteration | 27 |
About This Page
This page displays 50 FDA violation codes, collectively cited in 2,866 import refusal cases. These violations reference 41 distinct legal sections of FDA regulations. Each violation code links to detailed information including legal citations, affected firms, and case history.
Viewing page 4 of 6 • Showing violation codes #151-200 of 296 total