Violation Code: 318
FDA Violation
Charge Code: VITAMN LBL
Violation Details
- Violation Code (ASC ID)
- 318
- Charge Code
- VITAMN LBL
- Description
- The food appears to be subject to section 411 and its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2).
- Legal Section
- 403(a)(2), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Oladipupo H. Fashola | Lagcs, NIGERIA | 11 |
| 2 | Jugos Del Valle S A De C V | Tijuana Bc Mexico, MEXICO | 4 |
| 3 | Rummo Lenta Lavorazione Spa | Benevento, ITALY | 4 |
| 4 | Duga Komerc | Krusevac, SERBIA | 3 |
| 5 | OKF Corporation | Andong-si, SOUTH KORE | 3 |
| 6 | Exportadora Rio Grande S.A. De C.V. | San Salvador, EL SALVADO | 2 |
| 7 | Zhengtangzhuang Xiamen Healthcare Co., Ltd. | Fujian, CHINA | 2 |
| 8 | Mayberrys | Washington, UNITED STA | 1 |
| 9 | GRACE KENNEDY JAMAICA LTD. | Kingston, JAMAICA | 1 |
| 10 | Healthy People S de R.L. de CV | Irapuato, MEXICO | 1 |
| 11 | Flavour Makers / Passage Foods / Celebrate Health | Braeside, AUSTRALIA | 1 |
| 12 | Proterra Foods S.A.S. | Palmira, COLOMBIA | 1 |
| 13 | CNS PHARM | CHUNGCHEONGBUGDO, SOUTH KORE | 1 |
| 14 | English Biscuit Manufacturers (Pvt.) Ltd. | Karachi, PAKISTAN | 1 |
| 15 | NATURAL FARMS WAFERS & NAMKEEN | Mumbai, INDIA | 1 |
| 16 | HERITAGE GROUP LTD. | Dhaka, BANGLADESH | 1 |
| 17 | Tulsi Agriscale Impex LLP | Navi Mumbai, INDIA | 1 |
| 18 | GOSOBA SRL | San Cristobal, DOMINICAN | 1 |
| 19 | Ramico Foods Inc | Saint-Leonard, CANADA | 1 |
| 20 | Vanity Vision | Faridabad, INDIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/22/2025 | RASPBERRIES, RED (BERRY) 20AFD13 | MayberrysUNITED STA |
| 4/18/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | Vanity VisionINDIA |
| 8/22/2024 | CHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS 03HGT02 | GRACE KENNEDY JAMAICA LTD.JAMAICA |
| 6/10/2024 | PAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT) 21SFD06 | Proterra Foods S.A.S.COLOMBIA |
| 6/2/2024 | SPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C. 28KGT99 | HERITAGE GROUP LTD.BANGLADESH |
| 3/15/2024 | MACARONI ENRICHED 04AGT01 | |
| 2/5/2024 | MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. 21CGT99 | |
| 11/3/2023 | ACEROLA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VCY01 | GOSOBA SRLDOMINICAN |
| 8/23/2023 | GARBANZO BEAN 24AEE06 | Ramico Foods IncCANADA |
| 1/15/2019 | SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES 22KET04 | |
| 7/2/2018 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYT99 | |
| 3/28/2017 | HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) 33EGT99 | |
| 12/19/2016 | MIXED SPICES AND SEASONINGS, LIQUID, WITH SALT, N.E.C. 28LDI99 | |
| 12/13/2016 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCZ99 | CNS PHARMSOUTH KORE |
| 11/15/2016 | BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) 29RFT04 | Duga KomercSERBIA |
Frequently Asked Questions
What is FDA violation code 318?
318 is an FDA violation code that indicates: "The food appears to be subject to section 411 and its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2).". This violation is based on 403(a)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 318?
According to FDA Import Refusal data, there have been 48 import refusals issued for violation code 318, affecting 26 unique firms.
When was the most recent refusal for violation 318?
The most recent import refusal for violation 318 was on May 22, 2025.
What products are commonly refused for violation 318?
Products commonly refused under violation 318 include: RASPBERRIES, RED (BERRY), DIETARY CONVENTIONAL FOODS, N.E.C., CHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS, PAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT), SPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 318?
Violation code 318 is based on 403(a)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.