Violation Code: 335
FDA Violation
Charge Code: LACKS N/C
Violation Details
- Violation Code (ASC ID)
- 335
- Charge Code
- LACKS N/C
- Description
- 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.
- Legal Section
- 502(b)(2), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Best-pharm Ltd. | Moscow, RUSSIA | 92 |
| 2 | Church & Dwight Co., Inc. | Lakewood, UNITED STA | 31 |
| 3 | Bio Fresh Ltd. | Plovdiv, BULGARIA | 30 |
| 4 | Farmacia Homeopathica Vida | Zapopan, MEXICO | 22 |
| 5 | The Procter & Gamble Company | Cincinnati, UNITED STA | 22 |
| 6 | DCS EXPORT | Banbury, UNITED KIN | 17 |
| 7 | Korolevfarm | Korolev, RUSSIA | 14 |
| 8 | Europa Plus | Dnipropetrovsk, UKRAINE | 14 |
| 9 | Homeovitality Company | Preston, UNITED KIN | 10 |
| 10 | Won Cheol Lee | Seoulseoul, SOUTH KORE | 10 |
| 11 | ADI INDUSTRY CO LIMITED | Kowloon Bay, HONG KONG | 9 |
| 12 | Alltech do Brasil | Sao Pedro Do Ivai, BRAZIL | 9 |
| 13 | The Procter & Gamble Manufacturing Company | Greensboro, UNITED STA | 9 |
| 14 | Hindustan Unilever Ltd | Assam, INDIA | 8 |
| 15 | Cosmetique Active Production | La Roche Posay, FRANCE | 8 |
| 16 | Vichy Labs | Levallois, FRANCE | 7 |
| 17 | Kim Jeong Moon Aloe Co., Ltd. | Seoul, SOUTH KORE | 7 |
| 18 | S A Wilson | Ontario, CANADA | 7 |
| 19 | Lankan Delight | Gampaha District, SRI LANKA | 6 |
| 20 | COSMAX, INC. | Hwaseong-si, SOUTH KORE | 6 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/21/2025 | LASER THERAPY PRODUCT 95RHL | |
| 10/7/2025 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 9/26/2025 | FERRIC CITRATE (PHOSPHATE BINDER) 63LCK01 | New GPC Inc.GUYANA |
| 7/17/2025 | EMOLLIENT, LUBRICANT, N.E.C. 64DBO99 | Alcon Research LLCUNITED STA |
| 7/1/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCT99 | JOSE OROZCO HERNANDEZMEXICO |
| 5/27/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | |
| 5/27/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | Hamdard LaboratoriesINDIA |
| 4/25/2025 | ASTRINGENT/ANTI-PERSPIRANT N.E.C. 62WAL99 | |
| 3/12/2025 | FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) 61WDJ45 | WARIS IBTISAMUNITED ARA |
| 3/4/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | |
| 2/25/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | |
| 2/14/2025 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WAR17 | 9355-5878 quebec incCANADA |
| 2/14/2025 | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) 62WBY17 | |
| 2/5/2025 | DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) 62UBY11 | BELMORA LLCUNITED STA |
| 1/21/2025 | HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) 66PBQ05 | Johnson & Johnson Consumer IncUNITED STA |
Frequently Asked Questions
What is FDA violation code 335?
335 is an FDA violation code that indicates: "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.". This violation is based on 502(b)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 335?
According to FDA Import Refusal data, there have been 1363 import refusals issued for violation code 335, affecting 719 unique firms.
When was the most recent refusal for violation 335?
The most recent import refusal for violation 335 was on October 21, 2025.
What products are commonly refused for violation 335?
Products commonly refused under violation 335 include: LASER THERAPY PRODUCT, LAMP, INFRARED, THERAPEUTIC HEATING, FERRIC CITRATE (PHOSPHATE BINDER), EMOLLIENT, LUBRICANT, N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 335?
Violation code 335 is based on 502(b)(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.