Violation Codes
FDA violation codes ranked by frequency in import refusals
| # | Code | Description | Legal Section | Cases |
|---|---|---|---|---|
| 201 | 3859 TPFDA4BLBL | 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 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 compliance with regulatory requirements set by the FDA. | 903(a)(1); 801(a)(3); 301(tt)(4)(B); MISBRANDING | 26 |
| 202 | 3873 708NOREG | It has been determined the drug 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 | 26 |
| 203 | 170 CONTAM CAN | The article appears to be held in a container containing a poisonous or deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 25 |
| 204 | 3887 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 | 23 |
| 205 | 3100 ANDRO | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, 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 | 21 |
| 206 | 3883 708NODFL | The article lacks an OTC "Drug Facts" label as required by 21 CFR 201.66. | 502(c), 801(a)(3); MISBRANDING | 21 |
| 207 | 293 SHIGELLA | The article appears to contain Shigella, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 21 |
| 208 | 185 REDUCED | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength. | 501(d)(1), 801(a)(3); ADULTERATION | 19 |
| 209 | 2240 COSMETIC | The article is subject to refusal of admission pursuant Section 801(a)(3) in that The article appears to be an ingredient in a cosmetic product and may have been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. | 601(c), 801(a)(3); Adulteration | 18 |
| 210 | 2201 BSE FILTH | 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 | 18 |
| 211 | 173 IMITATION | The article appears to be an imitation of another food, and the label does not bear in type of uniform size and prominence, the word "imitation" and immediately thereafter, the name of the food imitated. | 403(c), 801(a)(3); MISBRANDING | 17 |
| 212 | 2981 BIO TOXIN | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain | 402(a)(1), 801(a)(3), Adulteration | 16 |
| 213 | 314 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. | 601(d), 801(a)(3); ADULTERATION | 15 |
| 214 | 268 CONCEALED | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be food which has damage or inferiority concealed in any manner. | 402(b)(3), 801(a)(3); ADULTERATION | 14 |
| 215 | 3602 DR PACKGNG | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading | 502(i) (1), 801(a)(3); MISBRANDING | 14 |
| 216 | 289 RECORDS | The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met. | 502(t), 801(a)(3); MISBRANDING | 14 |
| 217 | 339 TAMPERING | It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging. | 501(a)(2)(B), 801(a)(3); ADULTERATION | 14 |
| 218 | 3180 PATULIN | The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health. | 402(a)(1), 801(a)(3); ADULTERATION | 14 |
| 219 | 3872 708LISTING | It has been determined the drug is not included in a list required by Section 510(j). | 502(o), 801(a)(3); MISBRANDING | 13 |
| 220 | 300 NONNUT SUB | The article appears to be confectionery and it bears or contains a nonnutritive substance. | 402(d)(3), 801(a)(3); ADULTERATION | 12 |
| 221 | 154 FLUOROCARB | The article appears to contain chloroflurocarbons in violation of 21 CFR 2.125. | 402(a)(2)(A), 801(a)(3); ADULTERATION | 11 |
| 222 | 2840 BSE DRUGS | The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. | 501(a)(2)(A), 801(a)(1); Adulteration | 11 |
| 223 | 478 TISSUE | This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act. | 361 | 9 |
| 224 | 123 BANNED | The article appears to be a banned device. | 501(g), 801(a)(3); ADULTERATION | 8 |
| 225 | 286 POISON PKG | The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970. | 502(p), 801(a)(3); MISBRANDING | 8 |
| 226 | 2202 INSAN BSE | 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 rendered injurious to health. | 402(a)(4), 801(a)(3); Adulteration | 7 |
| 227 | 3899 NONRX505G | The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of section 502(ee) of the FD&C Act, under which a drug is deemed to be misbranded if it is a nonprescription drug that is subject to section 505G of the FD&C Act but does not comply with the requirements for marketing under said section 505G and is not the subject of an application approved under section 505 of the FD&C Act. | 801(a)(3), 502(ee); MISBRANDING | 7 |
| 228 | 3888 TPLABFALSE | 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 it appears that its labeling is false or misleading. | 903(a)(1); 801(a)(3); MISBRANDING | 6 |
| 229 | 3725 NONCOMELT | It appears that the article is an electronic product which fails to comply with one or more applicable standards prescribed under section 534. | 534, 536(a) | 6 |
| 230 | 3875 708REIMPRT | The article has been determined 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 | 6 |
| 231 | 3879 708UDECAPI | The article has been determined to contain an API that is undeclared on the label or accompanying labeling. | 502(a), 801(a)(3); MISBRANDING | 5 |
| 232 | 3895 NIOSH-EUA | The respirator is from a lot or shipment that failed testing and, pursuant to a condition of the applicable emergency use authorization (EUA), cannot be distributed. | Section 564(e), Conditions of Emergency Use Authorization | 5 |
| 233 | 3874 708NEWDRUG | The article has been determined to be a new drug without an approved new drug application. | 505(a), 801(a)(3); UNAPPROVED NEW DRUG | 5 |
| 234 | 3871 708NODIREC | The article has been determined to lack adequate directions for use. | 502(f)(1), 801(a)(3); MISBRANDING | 4 |
| 235 | 175 ALCOHOL | The article appears to be a confectionary that bears or contains alcohol in excess of 1/2 of 1% by volume derived solely from the use of flavoring extracts. | 402(d)(2), 801(a)(3); ADULTERATION | 4 |
| 236 | 122 ANTIBIOTIC | The drug appears to purport, or represented as, being composed wholly or partly of an antibiotic and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 507. REPEALED11/97 | 502(l), 801(a)(3); MISBRANDING | 4 |
| 237 | 3870 708NOENGL | Required label or labeling has been determined to not be in English in violation of 21 C.F.R. 201.15(c)(1). | 502(c); 801(a)(3) ;MISBRANDING | 4 |
| 238 | 509 NONSTEEL | Labeling appears false or misleading or fails to bear adequate directions for use,because the article appears to be misrepresented as a disposable single use instrument when it is intended for use as a stainless steel multi-use instrument. | 502(a) and/or 502(f)(1); Misbranding | 4 |
| 239 | 3889 TPADFALSE | 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) in that it appears that its advertising is false or misleading. | 903(a)(7)(A); 801(a)(3); MISBRANDING | 4 |
| 240 | 3866 708NEWANIM | The article has been determined to be a new animal drug without an approved new animal drug application. | 501(a)(5), 801(a)(3); ADULTERATION | 3 |
| 241 | 3901 VET DR LBL | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of Section 502(w) of the FD&C Act in that it appears to be a new animal drug ? | 502(w), 801(a)(3); MISBRANDING | 3 |
| 242 | 3020 STARANISE | The article appears to bear or contain a food additive, Japanese star anise, that is unsafe within the meaning of section 409. | 402(a)(2)(C)(i), 801(a)(3), Adulteration | 3 |
| 243 | 3853 TPLKDOMFOR | 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)(C) in that the label does not provide an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage foreign grown tobacco. | 903(a)(2)(C); 801(a)(3); MISBRANDING | 2 |
| 244 | 3661 INADQ PAST | The article is subject to refusal of admission pursuant to section 801 (a)(1) in that it appears to have been manufactured or processed under insanitary conditions which may result in unpasteurized or inadequately pasteurized product. | 402(a)(4), 801(a)(3); ADULTERATION | 2 |
| 245 | 3880 708FALSE | The labeling for this article is determined to be false or misleading | 502(a), 801(a)(3); MISBRANDING | 2 |
| 246 | 3908 3908 | No description available | — | 2 |
| 247 | 2660 2660 | No description available | — | 2 |
| 248 | 3903 3903 | No description available | — | 2 |
| 249 | 332 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. | 501(a)(3), 801(a)(3); ADULTERATION | 2 |
| 250 | 327 OPTION ING | It appears to be a food for which a definition and standard of identity have been prescribed by regulations under section 401 and appears to not be labelled with the common names of the optional ingredients specified therein. | 403(g)(2), 801(a)(3); MISBRANDING | 2 |
About This Page
This page displays 50 FDA violation codes, collectively cited in 504 import refusal cases. These violations reference 43 distinct legal sections of FDA regulations. Each violation code links to detailed information including legal citations, affected firms, and case history.
Viewing page 5 of 6 • Showing violation codes #201-250 of 296 total