Violation Codes
FDA violation codes ranked by frequency in import refusals
| # | Code | Description | Legal Section | Cases |
|---|---|---|---|---|
| 1 | 118 NOT LISTED | 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). | 502(o), 801(a)(3); MISBRANDING | 133692 |
| 2 | 75 UNAPPROVED | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA). | 505(a), 801(a)(3); UNAPPROVED NEW DRUG | 73905 |
| 3 | 249 FILTHY | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food. | 402(a)(3), 801(a)(3); ADULTERATION | 38720 |
| 4 | 482 NUTRIT LBL | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information. | 403(q); 801(a)(3); Misbranding | 35628 |
| 5 | 3280 FRNMFGREG | 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&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act. | 502(o), 801(a)(3); MISBRANDING | 30650 |
| 6 | 11 UNSAFE COL | The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a). | 402(c), 801(a)(3); ADULTERATION | 26251 |
| 7 | 9 SALMONELLA | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 23378 |
| 8 | 508 NO 510(K) | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed. | 801(a)(3); 502(o) Misbranding | 21771 |
| 9 | 341 REGISTERED | 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). | 502(o), 801(a)(3); MISBRANDING | 21657 |
| 10 | 83 NO PROCESS | 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. | 402(a)(4), 801(a)(3); ADULTERATION | 21145 |
| 11 | 218 LIST INGRE | 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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. | 403(i)(2), 801(a)(3); MISBRANDING | 20095 |
| 12 | 324 NO ENGLISH | 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 (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). | 403(f), 801(a)(3); MISBRANDING | 19659 |
| 13 | 241 PESTICIDE | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains: | 402(a)(2)(B), 801(a)(3); ADULTERATION | 18155 |
| 14 | 321 LACKS N/C | 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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act. | 403(e)(2), 801(a)(3); MISBRANDING | 16110 |
| 15 | 62 NEEDS FCE | 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). | 402(a)(4), 801(a)(3); ADULTERATION | 13735 |
| 16 | 473 LABELING | The article appears in violation of FPLA because of its placement, form and/or contents statement. | Section 4(a); 801(a)(3) Misbranding | 13081 |
| 17 | 16 DIRECTIONS | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use. | 502(f)(1), 801(a)(3); MISBRANDING | 10684 |
| 18 | 274 COLOR LBLG | The article appears to contain an artificial coloring and it fails to bear labeling stating that fact. | 403(k), 801(a)(3); MISBRANDING | 10000 |
| 19 | 3842 TP NO PMTA | 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 FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act. | 801(a)(3);902(6)(A);ADULTERATION | 9945 |
| 20 | 320 LACKS FIRM | 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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. | 403(e)(1), 801(a)(3); MISBRANDING | 8445 |
| 21 | 3843 TP NO SE | 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 FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j). | 801(a)(3);903(a)(6);MISBRANDING | 7103 |
| 22 | 328 USUAL 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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be. | 403(i)(1), 801(a)(3); MISBRANDING | 7093 |
| 23 | 471 CSTIC LBLG | 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. | 602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING | 6942 |
| 24 | 238 UNSAFE ADD | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409. | 402(a)(2)(C)(i), 801(a)(3); ADULTERATION | 6893 |
| 25 | 3854 TPLKUSSLLB | The 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)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations. | 903(a)(2)(D); 801(a)(3); MISBRANDING | 6752 |
| 26 | 197 COSM COLOR | 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). | 601(e), 801(a)(3); ADULTERATION | 6503 |
| 27 | 308 MFR INSAN | 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 | 6154 |
| 28 | 260 FALSE | 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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular. | 403(a)(1), 801(a)(3); MISBRANDING | 5126 |
| 29 | 251 POISONOUS | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: | 402(a)(1), 801(a)(3); ADULTERATION | 4971 |
| 30 | 256 INCONSPICU | 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 (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). | 403(f), 801(a)(3); MISBRANDING | 4714 |
| 31 | 47 NON STD | The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA. | 536(a),(b); NON STANDARD | 4683 |
| 32 | 3721 PESTICIDE2 | 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: | 402(a)(2)(B); 801(a)(3); ADULTERATION | 4540 |
| 33 | 306 INSANITARY | 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. | 402(a)(4), 801(a)(3); ADULTERATION | 4036 |
| 34 | 27 DRUG GMPS | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). | 501(a)(2)(B), 801(a)(3); ADULTERATION | 3954 |
| 35 | 237 NO PMA | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1). | 501(f)(1)(B), 801(a)(3); ADULTERATION | 3814 |
| 36 | 472 NO ENGLISH | Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1). | 502(c); 801(a)(3) ;MISBRANDING | 3622 |
| 37 | 2860 VETDRUGRES | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains | 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION | 3506 |
| 38 | 476 NO REGISTR | 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). | 536(a); Failure to file initial report | 3226 |
| 39 | 295 LISTERIA | The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 3187 |
| 40 | 2780 DEVICEGMPS | 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)(1); ADULTERATION | 3113 |
| 41 | 475 COSMETLBLG | 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. | 5(c)(3)(B); 801(a)(3) Misbranding | 3105 |
| 42 | 3421 MELAMINE | The article is subject to refusal of admission pursuant to section 801(a)(3) 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 | 2880 |
| 43 | 2920 PESTICIDES | 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: | 402(a)(2)(B), 802(a)(B); ADULTERATION | 2860 |
| 44 | 477 HOLES | The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes. | 501(c); 801(a)(3) Adulteration | 2799 |
| 45 | 2300 DIETARYLBL | 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)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient. | 403(s)(2)(B), 801(a)(3), misbranded | 2597 |
| 46 | 235 NOT IMPACT | The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410. | 501(c), 801(a)(3); ADULTERATION | 2590 |
| 47 | 72 NEW VET DR | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. | 501(a)(5), 801(a)(3); ADULTERATION | 2546 |
| 48 | 3300 ALLERGEN | the label fails to declare all major food allergens present in the product, as required by section 403(w)(1). | 403(w) 801(a)(3); Misbranding | 2436 |
| 49 | 333 LACKS FIRM | 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. | 502(b)(1), 801(a)(3); MISBRANDING | 2373 |
| 50 | 3886 FSVP VIO | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805. | 805, 801(a)(3); FOREIGN SUPPLIER VERIFICATION PROGRAM | 2352 |
About This Page
This page displays 50 FDA violation codes, collectively cited in 693,176 import refusal cases. These violations reference 42 distinct legal sections of FDA regulations. Each violation code links to detailed information including legal citations, affected firms, and case history.