Violation Code: 473
FDA Violation
Charge Code: LABELING
Violation Details
- Violation Code (ASC ID)
- 473
- Charge Code
- LABELING
- Description
- The article appears in violation of FPLA because of its placement, form and/or contents statement.
- Legal Section
- Section 4(a); 801(a)(3) Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | KALINA | Yekaterinburg, RUSSIA | 114 |
| 2 | Alnost Guatemala S.A | Guatemala, GUATEMALA | 78 |
| 3 | Rochef Chocolatier | Gatineau, CANADA | 72 |
| 4 | Omega Alpha Pharmaceuticals | Scarborough, CANADA | 70 |
| 5 | Eveline Cosmetics | Lesznowola, POLAND | 67 |
| 6 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 64 |
| 7 | FarmGroup | Barnaul, RUSSIA | 58 |
| 8 | Gup Rt | Kazan, RUSSIA | 49 |
| 9 | Sinoropa | Muriel, GERMANY | 48 |
| 10 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 48 |
| 11 | UNION MEDICO APS | Copenhagen, DENMARK | 48 |
| 12 | Mammola Funghi Di Bruno Romeo | Mammola, ITALY | 40 |
| 13 | Interactive Nutrition | Ottawa, CANADA | 38 |
| 14 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 37 |
| 15 | Simsek Biskuvi ve gida sanayii A.s. | Karaman, TURKEY | 37 |
| 16 | PLATINA COSMETICOS LTDA | Uberaba, BRAZIL | 35 |
| 17 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 35 |
| 18 | Popat Raja & Sons | Mumbai, INDIA | 34 |
| 19 | Bescon Co., Ltd. | Cheonan-City, SOUTH KORE | 33 |
| 20 | Ravi Spice Processors Pvt Ltd. | Bengaluru, INDIA | 32 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | APPLE, CORE FRUIT JUICES OR CONCENTRATES 20SGY01 | |
| 12/17/2025 | CHILI SAUCE 37JCT03 | |
| 12/17/2025 | ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.) 04CGT08 | |
| 12/17/2025 | PROTEIN N.E.C. 54CCU99 | |
| 12/17/2025 | SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) 33JGT99 | |
| 12/17/2025 | TOMATO SAUCE (WITH OTHER INGREDIENTS) 37JHT08 | |
| 12/16/2025 | SYRUP (PHARMACEUTIC NECESSITY - FLAVOR) 55QP13 | |
| 12/16/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SFY99 | cadbury nigeria plcNIGERIA |
| 12/16/2025 | ANTI-ECZEMATIC N.E.C. 61SBJ99 | |
| 12/16/2025 | MELON SEEDS (EDIBLE SEED PASTE) 23RGY05 | |
| 12/16/2025 | BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) 64LMJ06 | |
| 12/16/2025 | LEAF & STEM VEGETABLES, DRIED OR PASTE, N.E.C. 24UGH99 | |
| 12/16/2025 | PUMPKIN SEED (EDIBLE SEED) 23KGH01 | |
| 12/16/2025 | BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) 24AYH99 | |
| 12/16/2025 | MANGO, GROUND, CRACKED SPICE 28BHN64 |
Frequently Asked Questions
What is FDA violation code 473?
473 is an FDA violation code that indicates: "The article appears in violation of FPLA because of its placement, form and/or contents statement.". This violation is based on Section 4(a); 801(a)(3) Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 473?
According to FDA Import Refusal data, there have been 13081 import refusals issued for violation code 473, affecting 5128 unique firms.
When was the most recent refusal for violation 473?
The most recent import refusal for violation 473 was on December 31, 2025.
What products are commonly refused for violation 473?
Products commonly refused under violation 473 include: APPLE, CORE FRUIT JUICES OR CONCENTRATES, CHILI SAUCE, ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.), PROTEIN N.E.C., SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 473?
Violation code 473 is based on Section 4(a); 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.