Violation Codes
FDA violation codes ranked by frequency in import refusals
| # | Code | Description | Legal Section | Cases |
|---|---|---|---|---|
| 251 | 3601 IMITN DR | 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: | 502(i) (2), 801(a)(3); MISBRANDING | 2 |
| 252 | 3910 3910 | No description available | — | 1 |
| 253 | 3801 FALSERXLBL | The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act 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". | 503(b)(4)(B), 801(a)(3) | 1 |
| 254 | 3867 708NORX | The article has been determined to be a a prescription drug without a prescription drug legend. | 502(a) & (f)(1), 801(a)(3); MISBRANDING | 1 |
| 255 | 2220 INGRED FIL | 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. | 402(a)(4), 801(a)(3); Adulteration | 1 |
| 256 | 3858 TPFDA4ALBL | 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 misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its regulation or inspection by the FDA. | 903(a)(1); 801(a)(3); 301(tt)(4)(A); MISBRANDING | 1 |
| 257 | 2341 DIOXIN | 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. | 402(a)(1),402(a)(2)(A),402(a)(2)(C)(i),801(a)(3)-Adulterated | 1 |
| 258 | 3540 NO EXP DAT | 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. | 402(g), 801(a)(3); ADULTERATION | 1 |
| 259 | 74 GINSENG | The article appears to bear or contain "Ginseng", a food additive which is unsafe within the meaning of Section 409. | 402(a)(2)(C), 801(a)(3); ADULTERATION | 1 |
| 260 | 9999985 9999985 | No description available | — | 1 |
| 261 | 9999975 9999975 | No description available | — | 1 |
| 262 | 3440 MELAMINE | 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. | 402(a)(2)(C)(i), 801(a)(3); ADULTERATION | 1 |
| 263 | 3907 3907 | No description available | — | 1 |
| 264 | 3891 TPADULT1 | 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 adulterated under section 902(1) because it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health. | 902(1);801(a)(3); ADULTERATION | 1 |
| 265 | 3869 708LBLFIRM | The article has been determined to to not bear a label containing the name and place of business of the manufacturer, packer, or distributor. | 502(b)(1), 801(a)(3); MISBRANDING | 1 |
| 266 | 3420 MELAMINE | 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. | 402(a)(1), 801(a)(3), Adulteration | 1 |
| 267 | 3876 GDUFA FEE | 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(aa) of the Act. It appears the drug or active pharmaceutical ingredient was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required in 21 U.S.C. Section 379j-42(a)(4), or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility. | 502(aa), 801(a)(3);MISBRANDING | 0 |
| 268 | 3782 TPLBLFALSE | 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.") | 903(a)(1);801(a)(3);MISBRANDING | 0 |
| 269 | 3848 TP NO ING | 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 misbranded under section 903(a)(10)(A) in that a list of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or part of each tobacco product by brand and by quantity in each brand and sub-brand was not submitted as required under section 904(a)(1). | 903(a)(10)(A); 801(a)(3) MISBRANDING | 0 |
| 270 | 2740 DR QUALITY | No description available | 501b | 0 |
| 271 | 316 *** | 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. | 402(a)(5), 801(a)(3); ADULTERATION | 0 |
| 272 | 3884 ADDDRUGBIO | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies. | 801(a)(3);301(ll); PROHIBITED ACT | 0 |
| 273 | 2100 POISONOUS | listeria | 402(A)(3) | 0 |
| 274 | 2820 CALIBRATED | The article is subject to refusal in that it is calibrated in units not commonly used in the United States | 502(f)(1); 801(a)(3), misbranding | 0 |
| 275 | 3877 GDUFA SELF | 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(aa) of the Act. It appears that the drug or active pharmaceutical ingredient was manufactured, prepared, propagated, compounded, or processed in a facility for which identifying information required by 21 U.S.C. Section 379j-42(f) has not been submitted, or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility. | 502(aa),801(a)(3); MISBRANDING | 0 |
| 276 | 2400 COLOR | No description available | 601% | 0 |
| 277 | 3857 TPFDA3LBLG | 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 misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is endorsed by the FDA for use by consumers. | 903(a)(1); 801(a)(3); 301(tt)(3); MISBRANDING | 0 |
| 278 | 3861 CYCLAMATE | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated because it appears to bear or contain an unsafe food additive that is unsafe within the meaning of Section 409. | 801(a)(3) | 0 |
| 279 | 3882 708NORX | The article has been determined to be a prescription drug but does not include the symbol "Rx only" on its label. | 503(b)(4), 801(a)(3); MISBRANDING | 0 |
| 280 | 481 LBL STEEL | 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. | 502(a); 801(a)(3); Misbranding | 0 |
| 281 | 346 REJECT TEA | The article is inferior in purity, quality, and fitness for consumption to the standards provided in section 43.TEA ACT REPEALED! | 1 (21USC41); PROHIBITED TEA | 0 |
| 282 | 3850 TPNOHLDOCS | 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 misbranded under section 903(a)(10)(A) in that documents related to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents(including smoke constituents), ingredients, components, and additives were not submitted as required under section 904(a)(4). | 903(a)(10)(A); 801(a)(3) MISBRANDING | 0 |
| 283 | 3890 TPPACKSIZE | This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a cigarette package that contains fewer than 20 cigarettes in violation of 21 CFR 1140.16(b). [Misbranded: Section 903(a)(7)(B) of the FD&C Act] | 906(d); 903(a)(7)(B); 801(a)(3); MISBRANDING | 0 |
| 284 | 3603 OTHER DRUG | 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. | 502(i) (3), 801(a)(3); MISBRANDING | 0 |
| 285 | 3726 ELTNOCERT | 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). | 534, 536(a) | 0 |
| 286 | 189 FLUOROCARB | The article appears to contain chloroflurocarbons in violation of 21 CFR Part 2.125. | 601(a), 801(a)(3); ADULTERATION | 0 |
| 287 | 3856 TPFDA2LBLG | 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 misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the FDA deems the product to be safe for use by consumers. | 903(a)(1); 801(a)(3); 301(tt)(2); MISBRANDING | 0 |
| 288 | 3855 TPFDA1LBLG | 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 misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is approved by the FDA. | 903(a)(1); 801(a)(3); 301(tt)(1); MISBRANDING | 0 |
| 289 | 3892 TPADULT2 | 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 adulterated under section 902(2) because it has 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. | 902(2);801(a)(3); ADULTERATION | 0 |
| 290 | 3723 RXVETLACK2 | The article appears to be a veterinary drug which requires but lacks the "Caution" statement specified at Sec. 503(f)(4). | 503(f)(4), 801(a)(3) | 0 |
| 291 | 3722 RXVETLACK | The article appears to be a drug which requires a prescription from your doctor. | 503(f)(4), 801(a)(3) | 0 |
| 292 | 283 INSULIN | 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 | 502(k), 801(a)(3); MISBRANDING | 0 |
| 293 | 188 FLUOROCARB | The article appears to be a new animal drug containing chloroflurocarbons in violation of 21 CFR 2.125. | 501(a)(5), 801(a)(3); ADULTERATION | 0 |
| 294 | 3849 TP NO HPHC | 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 misbranded under section 903(a)(10)(A) in that a listing of constituents, including smoke constituents, identified as harmful or potentially harmful to health in each tobacco product was not submitted as required under section 904(a)(3). | 903(a)(10)(A); 801(a)(3) MISBRANDING | 0 |
| 295 | 3868 708VETLGND | The article has been determined to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4). | 502(a) & (f)(1), 801(a)(3); MISBRANDING | 0 |
| 296 | 3893 TPADULT3 | 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 adulterated under section 902(3) because its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. | 902(3);801(a)(3); ADULTERATION | 0 |
About This Page
This page displays 46 FDA violation codes, collectively cited in 17 import refusal cases. These violations reference 38 distinct legal sections of FDA regulations. Each violation code links to detailed information including legal citations, affected firms, and case history.
Viewing page 6 of 6 • Showing violation codes #251-296 of 296 total