Violation Codes
FDA violation codes ranked by frequency in import refusals
| # | Code | Description | Legal Section | Cases |
|---|---|---|---|---|
| 101 | 3520 TP FLAVOR | This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907 (a) (1) (A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke. | 902(a)(5), 927(a)(1)(A), 801(a)(3); ADULTERATION | 384 |
| 102 | 330 UNSAFE COL | 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). | 501(a)(4)(B), 801(a)(3); ADULTERATION | 383 |
| 103 | 3878 POISONORD | 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 which would ordinarily render the article injurious to health. Contains: | 402(a)(1), 801(a)(3); ADULTERATION | 374 |
| 104 | 3862 DIETARYING | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend. | 403(s)(2)(A),801(a)(3); MISBRANDING | 372 |
| 105 | 3904 3904 | No description available | — | 366 |
| 106 | 2680 SACCHARLBL | The article contains Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient | 403(i); 803(a)(3) Misbranding | 366 |
| 107 | 178 COL ADDED | 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). | 501(a)(4)(A), 801(a)(3); ADULTERATION | 351 |
| 108 | 3905 3905 | No description available | — | 341 |
| 109 | 2720 DULCIN | The article appears to bear or contain dulcin, an unsafe food additive within the meaning of Section 409 | 402(a)(2)(C); 801(a)(3) | 338 |
| 110 | 3560 SUPPL GMP | 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. | 402(g)(1), Adulteration, 801(a)(3), Adulteration | 329 |
| 111 | 331 DR QUALITC | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that 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. | 501(c), 801(a)(3); ADULTERATION | 294 |
| 112 | 3863 PLANT PART | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. | 403(s)(2)(C), 801(a)(3); MISBRANDING | 286 |
| 113 | 2380 NO PMA/PDP | 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). | 501(f)(1)(A); 801(a)(3); ADULTERATION | 283 |
| 114 | 186 INSANITARY | The article is subject to refusal of admission pursuant to section 801(a)(3) in that 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. | 501(a)(2)(A), 801(a)(3); ADULTERATION | 282 |
| 115 | 3852 TPLACKSNC | 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 in package form that appears to be misbranded under section 903(a)(2)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count. | 903(a)(2)(B); 801(a)(3); MISBRANDING | 279 |
| 116 | 171 CONTAINER | 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. | 402(a)(6), 801(a)(3); ADULTERATION | 279 |
| 117 | 3898 INADPRCCTL | 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 become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate process controls. | 402(a)(4), 801(a)(3); ADULTERATION | 273 |
| 118 | 3865 COLORLABEL | 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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use. | 403(f);801(a)(3);MISBRANDING | 273 |
| 119 | 3000 N-RX INACT | 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. | 502(e)(1); 801(a)(3); Misbranding | 261 |
| 120 | 313 HELD INSAN | 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. | 601(c), 801(a)(3); ADULTERATION | 243 |
| 121 | 115 DR QUALITY | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that 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. | 501(b), 801(a)(3); ADULTERATION | 236 |
| 122 | 342 PERSONALRX | The article appears to be a drug which requires a prescription from your doctor. | 502(a) & (f)(1), 801(a)(3); MISBRANDING | 235 |
| 123 | 319 WRONG IDEN | 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 as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food. | 403(b), 801(a)(3); MISBRANDING | 234 |
| 124 | 265 SUBSTITUTE | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients. | 402(b)(2), 801(a)(3); ADULTERATION | 226 |
| 125 | 3600 REFUSE EI | 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. | 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING | 223 |
| 126 | 117 DANGEROUS | 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. | 502(j), 801(a)(3); MISBRANDING | 221 |
| 127 | 2460 UNSFDIETLB | 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. | 402(f)(1)(A), 801(a)(3) Adulteration | 203 |
| 128 | 3681 NCONTACTS | 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. | 403(y), 801(2)(3); Misbranding | 195 |
| 129 | 3621 JUICEHACCP | 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. | 801(a)(3);402(a)(4) | 191 |
| 130 | 3140 SBGINSENG | 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. | 801(a)(3); 403(u) Misbranding | 189 |
| 131 | 82 RX LEGEND | The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4). | 502(a) & (f)(1), 801(a)(3); MISBRANDING | 188 |
| 132 | 3844 SACCHARLBL | The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient. | 403(i), 801(a)(3); Misbranding | 180 |
| 133 | 262 DIETARY | 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. | 403(j), 801(a)(3); MISBRANDING | 166 |
| 134 | 309 FORBIDDEN | The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported. | 801(a)(2); FORBIDDEN OR RESTRICTED IN SALE | 162 |
| 135 | 325 STD NAME | 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(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation. | 403(g)(2), 801(a)(3); MISBRANDING | 152 |
| 136 | 2200 DIET INGRE | 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. | 402(a)(3), 801(a)(3); Adulteration | 147 |
| 137 | 3380 EXPIRED | 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. | 501(c); 801(a)(3) Adulteration | 145 |
| 138 | 2800 POSS N/STR | The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms | 501(a)(1); 801(a)(3) ADULTERATION | 144 |
| 139 | 487 SACCHARIN | The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement. | 403(o); 801(a)(3) Misbranded | 142 |
| 140 | 245 EXCESS SUL | The article appears to contain excessive sulfites, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 142 |
| 141 | 484 DV NAME | The article appears to be a device and its labeling fails to bear the proprietary or established name. | 502(e)(2); 801(a)(3); Misbranding | 135 |
| 142 | 3894 TPNICWARN | 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)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco." | 903(a)(7)(B); 801(a)(3); MISBRANDING | 132 |
| 143 | 315 ADDED BULK | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that 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. | 402(b)(4), 801(a)(3); ADULTERATION | 131 |
| 144 | 3200 COSM MISB2 | 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. | 602(a) & 801(a)(3); MISBRANDING | 128 |
| 145 | 3841 AF-NONRSP | 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 acidified food pursuant to 21 CFR 108.25 (c)(2) appears to be inadequate to protect the public health. | 402(a)(4), 801(a)(3);ADULTERATION | 111 |
| 146 | 2020 LBLG ADVER | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual. | 502(a), 201(n) and 801(a)(3) Misbranding | 110 |
| 147 | 312 FILTH | The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance. | 601(b), 801(a)(3); ADULTERATION | 110 |
| 148 | 3724 DEVGMPS | 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). | 520(f); 801(a)(1) | 110 |
| 149 | 254 STD QUALIT | 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)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a standard of quality has been prescribed by regulation as provided by Section 401 of the FD&C Act, and its quality falls below such standard 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)(1), 801(a)(3); MISBRANDING | 109 |
| 150 | 3500 RXLABEL | The labeling fails to bear, at a minimum, the symbol "RX Only". | 503(b)(4)(A), 801(a)(3); MISBRANDING | 104 |
About This Page
This page displays 50 FDA violation codes, collectively cited in 11,258 import refusal cases. These violations reference 46 distinct legal sections of FDA regulations. Each violation code links to detailed information including legal citations, affected firms, and case history.
Viewing page 3 of 6 • Showing violation codes #101-150 of 296 total