Violation Code: 484
FDA Violation
Charge Code: DV NAME
Violation Details
- Violation Code (ASC ID)
- 484
- Charge Code
- DV NAME
- Description
- The article appears to be a device and its labeling fails to bear the proprietary or established name.
- Legal Section
- 502(e)(2); 801(a)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | TECNO INSTRUMENTS (PVT.) LTD. | Sialkot, PAKISTAN | 22 |
| 2 | Daemaik Industrial Co., Ltd. | Pusan, SOUTH KORE | 10 |
| 3 | Qingdao London Durex Co., Ltd. | Qingdao, CHINA | 5 |
| 4 | BSN Medical SA de CV | Reynosa, MEXICO | 5 |
| 5 | Kaneko Cord | Shizuoka, JAPAN | 3 |
| 6 | Shijiazhuang Junfei Plastic Products Co., ltd. | Shijiazhuang, CHINA | 3 |
| 7 | Bionet Co., Ltd. | Anyang, SOUTH KORE | 3 |
| 8 | AL-KHAIR CREATIVE QUALITY WARE | Karachi, PAKISTAN | 2 |
| 9 | ZHEJIANG YUANTONG MEDICAL APPLIANCES CO LTD | Hangzhou, CHINA | 2 |
| 10 | WUHAN PHOMED TECHNOLOGY CO LTD | Wuhan, CHINA | 2 |
| 11 | Laboratorios Le Roy, S.A. de C.V. | Yecapixtla, MEXICO | 2 |
| 12 | Atlantic Enterprises | Sialkot, PAKISTAN | 2 |
| 13 | Glory Hill Industrial | Dongguan, CHINA | 2 |
| 14 | Bricon Technology GmbH | Wurmlingen, GERMANY | 1 |
| 15 | Armco Products | Glendora, UNITED STA | 1 |
| 16 | Beijing Vca Laser Technology Co. Ltd. | Beijing, CHINA | 1 |
| 17 | Anteis Sa | Plan-les-ouates, SWITZERLAN | 1 |
| 18 | Beijing Starlight Science &Technology Develpopment | Shanghai, CHINA | 1 |
| 19 | Columbia Dentform | Lancaster, UNITED STA | 1 |
| 20 | BATMOH ENTERPRISE | Accra, GHANA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/21/2025 | LASER THERAPY PRODUCT 95RHL | |
| 10/7/2025 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 8/11/2025 | CANNULA, CATHETER 74DQR | |
| 5/14/2025 | CONDOM 85HIS | |
| 5/13/2025 | CONDOM 85HIS | |
| 5/13/2025 | CONDOM 85HIS | |
| 5/13/2025 | CONDOM 85HIS | |
| 5/13/2025 | CONDOM 85HIS | |
| 12/17/2024 | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) 53IG01 | BATMOH ENTERPRISEGHANA |
| 7/14/2022 | NEBULIZER (DIRECT PATIENT INTERFACE) 73CAF | |
| 7/14/2022 | NEBULIZER (DIRECT PATIENT INTERFACE) 73CAF | |
| 4/19/2022 | MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT 79PBX | |
| 11/9/2021 | MASK, SURGICAL 80FXX | |
| 11/4/2021 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | CB VISION GROUP LTDHONG KONG |
| 7/30/2021 | VACUUM POWERED BODY FLUID COLLECTION KIT 79OJR |
Frequently Asked Questions
What is FDA violation code 484?
484 is an FDA violation code that indicates: "The article appears to be a device and its labeling fails to bear the proprietary or established name.". This violation is based on 502(e)(2); 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 484?
According to FDA Import Refusal data, there have been 135 import refusals issued for violation code 484, affecting 85 unique firms.
When was the most recent refusal for violation 484?
The most recent import refusal for violation 484 was on October 21, 2025.
What products are commonly refused for violation 484?
Products commonly refused under violation 484 include: LASER THERAPY PRODUCT, LAMP, INFRARED, THERAPEUTIC HEATING, CANNULA, CATHETER, CONDOM. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 484?
Violation code 484 is based on 502(e)(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.