Violation Codes
FDA violation codes ranked by frequency in import refusals
| # | Code | Description | Legal Section | Cases |
|---|---|---|---|---|
| 51 | 488 HEALTH C | 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 bears an unauthorized nutrient content/health claim. | 801(a)(3); 403(r)(1)(A)/(B) misbranding | 2321 |
| 52 | 2120 UNSFDIETSP | 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. | 402(f)(1)(B), 801(a)(3) Adulteration | 2222 |
| 53 | 3821 MFR INJ | 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. | 402(a)(4),801(a)(3); ADULTERATION | 2202 |
| 54 | 290 DE IMP GMP | The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f). | 801(a)(1); NON CONFORMING MANUFACTURING PRACTICES | 1993 |
| 55 | 179 AGR RX | 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. | 801(d)(1),(2); IMPORTATION RESTRICTED | 1895 |
| 56 | 336 INCONSPICU | 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. | 502(c), 801(a)(3); MISBRANDING | 1664 |
| 57 | 3864 NCONTACT | 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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. | 403(y), 801(a)(3); MISBRANDING | 1664 |
| 58 | 223 FALSE | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading. | 502(a), 801(a)(3); MISBRANDING | 1649 |
| 59 | 64 YELLOW #5 | 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. | 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING | 1596 |
| 60 | 3422 UNFIT4FOOD | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food. | 402(a)(3), 801(a)(3); ADULTERATION | 1543 |
| 61 | 3851 TPLACKFIRM | This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor. | 903(a)(2)(A); 801(a)(3); MISBRANDING | 1430 |
| 62 | 3320 TRANSFAT | 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)]. | 403(q), 801(a)(3) ;MISBRANDING | 1398 |
| 63 | 479 DV QUALITY | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. | 501(c); 801(a)(3) Adulteration | 1386 |
| 64 | 335 LACKS N/C | 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. | 502(b)(2), 801(a)(3); MISBRANDING | 1365 |
| 65 | 483 DRUG NAME | 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. | 502(e)(1); 801(a)(3); Misbranding | 1332 |
| 66 | 2280 DIRSEXMPT | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use. | 502(f)(1), 801(a)(3); MISBRANDING | 1327 |
| 67 | 2480 RXPERSONAL | The article appears to be a device which requires a prescription from your doctor. | 502(a), 502(f)(1), 801(a)(3), MISBRANDING | 1317 |
| 68 | 2580 MFRHACCP | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a). | 402(a)(4), 801(a)(3) | 1293 |
| 69 | 253 STD IDENT | 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)(1) 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 by section 401 of the FD&C Act and the article does not conform to such definition and standard. | 403(g)(1), 801(a)(3); MISBRANDING | 1160 |
| 70 | 480 STAINSTEEL | 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. | 501(c); 801(a)(3) Adulteration | 1117 |
| 71 | 3260 NO ENGLISH | Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) | 502(c); 801(a)(3);Misbranding | 1105 |
| 72 | 3741 FRNMFGREG | 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. | 510(i); 801(o) | 1103 |
| 73 | 2360 HISTAMINE | The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health. | 402(a)(1), 801(a)(3); Adulteration | 1085 |
| 74 | 474 COSMETLBLG | It appears the label does not bear the common or usual name of the cosmetic. | 5(c)(3)(A); 801(a)(3) Misbranding | 1013 |
| 75 | 276 PRESRV LBL | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function. | 403(k), 801(a)(3); MISBRANDING | 1008 |
| 76 | 3220 NITROFURAN | The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely nitrofurans, that is unsafe. | 402(a)(2)(C)(i), 801(a)(3); Adulteration | 974 |
| 77 | 2040 SULFITELBL | 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, 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. | 403(a)(1), 801(a)(3) ;MISBRANDING | 893 |
| 78 | 198 COLOR LBLG | The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721. | 602(e), 801(a)(3); MISBRANDING | 883 |
| 79 | 84 RX DEVICE | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109. | 502(a),(f)(1), 801(a)(3); MISBRANDING | 878 |
| 80 | 181 UNDER PRC | 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. | 402(a)(4), 801(a)(3); ADULTERATION | 814 |
| 81 | 3881 COSMETFPLA | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act. | 1454(c)(3)(B), 1456, 801(a)(3) | 749 |
| 82 | 297 AFLATOXIN | The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 731 |
| 83 | 329 JUICE % | 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 the food purports to be 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. | 403(i)(2), 801(a)(3); MISBRANDING | 728 |
| 84 | 126 FAILS STD | 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. | 501(e), 801(a)(3); ADULTERATION | 702 |
| 85 | 310 POISONOUS | The article is subject to refusal of admission pursuant Section 801(a)(3) in that 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. | 601(a), 801(a)(3); ADULTERATION | 692 |
| 86 | 231 LENS CERT | 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. | 502(a), 801(a)(3); MISBRANDING | 662 |
| 87 | 2640 CYCLAMATE | The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409 | 402(a)(2)(C); 801(a)(3) | 636 |
| 88 | 278 NO TAG | 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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h). | 536(a),(b); NOT CERTIFIED | 566 |
| 89 | 3400 PB-FOOD | 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. | 402(a)(1); 801(a)(3); Adulteration | 561 |
| 90 | 71 NO LICENSE | The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use | 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT | 539 |
| 91 | 78 STERILITY | 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 contaminated with filth, or whereby it may have been rendered injurious to health. | 501(a)(2)(A), 801(a)(3); ADULTERATION | 510 |
| 92 | 258 FLAVR LBLG | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact. | 403(k), 801(a)(3); MISBRANDING | 509 |
| 93 | 156 NO 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). | 1, 2; PROHIBITION WITHOUT PERMIT | 506 |
| 94 | 281 BACTERIA | The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains | 402(a)(1), 801(a)(3); ADULTERATION | 487 |
| 95 | 48 NEEDS ACID | 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 acidification. | 402(a)(4), 801(a)(3); ADULTERATION | 458 |
| 96 | 3781 TPNOWRNLBL | This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e., one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act). | 903(a)(8)(B)(i);801(a)(3);MISBRANDING | 452 |
| 97 | 344 WARNINGS | 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. | 502(f)(2), 801(a)(3); MISBRANDING | 420 |
| 98 | 2900 CHLORAMP | The article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. 348. | 402(a)(2)(C)(i), 801(a)(3); ADULTERATION | 402 |
| 99 | 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 | 395 |
| 100 | 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 | 391 |
About This Page
This page displays 50 FDA violation codes, collectively cited in 52,726 import refusal cases. These violations reference 45 distinct legal sections of FDA regulations. Each violation code links to detailed information including legal citations, affected firms, and case history.
Viewing page 2 of 6 • Showing violation codes #51-100 of 296 total