Violation Code: 3280
FDA Violation
Charge Code: FRNMFGREG
Violation Details
- Violation Code (ASC ID)
- 3280
- Charge Code
- FRNMFGREG
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
- Legal Section
- 502(o), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | F.L. Medical S.R.L. | Padova, ITALY | 153 |
| 2 | Jr Beauty Enterprise Sdn Bhd | Kuala Lumpur, MALAYSIA | 139 |
| 3 | Nakanishi Optical Products Corp. | Osaka, JAPAN | 130 |
| 4 | Barberini Lenti Specia | Silvi, ITALY | 123 |
| 5 | P.T. Nipro Indonesia Jaya | Karawang, INDONESIA | 121 |
| 6 | A.H. GEIGER | Lorrach, GERMANY | 119 |
| 7 | SKYLINE HANDELS GMBH | Vienna, AUSTRIA | 119 |
| 8 | STERIMED SURGICALS (INDIA) PVT | New Delhi, INDIA | 115 |
| 9 | SHENZHEN DONGJILIAN ELECTRONICS CO., LTD | Shenzhen, CHINA | 108 |
| 10 | Funky Vision Ltd | Louth, UNITED KIN | 108 |
| 11 | SOLOTICA INDUSTRIA E COMERCIO LTDA | Sao Paulo, BRAZIL | 107 |
| 12 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 102 |
| 13 | Johnson & Johnson Vision Care, Inc. | Jacksonville, UNITED STA | 99 |
| 14 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 94 |
| 15 | Luxottica Spa | Milan, ITALY | 88 |
| 16 | Lafont | Paris, FRANCE | 84 |
| 17 | MAQUET SUZHOU COMPANY LTD | Suzhou, CHINA | 82 |
| 18 | NIPRO CORP. | Odate, JAPAN | 75 |
| 19 | Maui Jim, Inc. | Peoria, UNITED STA | 75 |
| 20 | MicroVention Costa Rica S.R.L. | Alajuela, COSTA RICA | 72 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. 83QKP | |
| 1/22/2026 | OVER-THE-COUNTER COVID-19 ANTIGEN TEST 83QYT | ALTRUANGERMANY |
| 1/22/2026 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IY01 | NELSON NATURALS INCCANADA |
| 1/22/2026 | ONABOTULINUMTOXINA 58PCZ05 | Merz Pharma GmbH & Co., KGaAGERMANY |
| 1/22/2026 | FACIAL IMPLANT 79ODU | DENTOLINECOLOMBIA |
| 1/22/2026 | SODIUM CHLORIDE (REPLENISHER) 65RCK19 | FRESENIUS KABI BIDIPHAR JSCVIETNAM |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YCY99 | WWW.R3JUVEN8.ETAUSTRALIA |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YMY99 | LDI LAPUKE DRUG INCPHILIPPINE |
| 1/22/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YRY99 | LDI LAPUKE DRUG INCPHILIPPINE |
| 1/22/2026 | COMPONENTS, WHEELCHAIR 89KNN | HL CORP SHENZHENCHINA |
| 1/22/2026 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | Merz North America, Inc.UNITED STA |
| 1/22/2026 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | |
| 1/22/2026 | MOUTHGUARD 76MQC | GLIDEWELL MEXICOMEXICO |
| 1/22/2026 | TITANIUM DIOXIDE (PROTECTANT) 65LBJ11 | COIZ Co., Ltd.SOUTH KORE |
| 1/22/2026 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PBY99 | COSRX INCSOUTH KORE |
Related Violations
Other violations under the same legal section: 502(o), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3280?
3280 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.". This violation is based on 502(o), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3280?
According to FDA Import Refusal data, there have been 30787 import refusals issued for violation code 3280, affecting 14363 unique firms.
When was the most recent refusal for violation 3280?
The most recent import refusal for violation 3280 was on January 22, 2026.
What products are commonly refused for violation 3280?
Products commonly refused under violation 3280 include: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM., OVER-THE-COUNTER COVID-19 ANTIGEN TEST, DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS), ONABOTULINUMTOXINA, FACIAL IMPLANT. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3280?
Violation code 3280 is based on 502(o), 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.