Violation Code: 341
FDA Violation
Charge Code: REGISTERED
Violation Details
- Violation Code (ASC ID)
- 341
- Charge Code
- REGISTERED
- Description
- It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
- Legal Section
- 502(o), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | DreamCon Co. Ltd. | Yangsan, SOUTH KORE | 288 |
| 2 | Voco GmbH | Cuxhaven, GERMANY | 266 |
| 3 | Shanghai Jiu He Import And Export Co. | Shanghai, CHINA | 166 |
| 4 | Nobel Biocare | The Netherlands, NETHERLAND | 134 |
| 5 | EPPENDORF AG | Hamburg, GERMANY | 133 |
| 6 | Tomey Corporation | Nagoya, JAPAN | 126 |
| 7 | Agfa Gevaert NV | Mortsel, BELGIUM | 83 |
| 8 | Nipro Corporation | Osaka, JAPAN | 74 |
| 9 | LINHAISHI WANDA GLASSES FACTORY | LINHAI, CHINA | 68 |
| 10 | Ge Healthcare Logistique France | Cedex, FRANCE | 67 |
| 11 | Stryker Trauma GmbH | Schonkirchen, GERMANY | 65 |
| 12 | Nissho Corporation | Osaka, JAPAN | 63 |
| 13 | Dentech Corp. | Itabashi, JAPAN | 61 |
| 14 | Labtician Ophthalmics Inc. | Oakville, CANADA | 60 |
| 15 | Luxottica Group S.P.A. | AGORDO, ITALY | 54 |
| 16 | Shanghai Neo-Medical Import & Export Co., Ltd. | Shanghai, CHINA | 53 |
| 17 | NIPRO CORP. | Odate, JAPAN | 49 |
| 18 | Elmed Instruments Pvt. Ltd. | Sialkot, PAKISTAN | 48 |
| 19 | Beijing Reagent Latex Products Co., Ltd. | Beijing, CHINA | 48 |
| 20 | K T Surgico (PVT) Ltd. | Sialkot, PAKISTAN | 47 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/29/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | Pf Concept International B.V.NETHERLAND |
| 12/29/2025 | SCREW, FIXATION, INTRAOSSEOUS 76DZL | ARUMSOUTH KORE |
| 12/23/2025 | DEVICE, FLUSH, VASCULAR ACCESS 80NGT | |
| 12/22/2025 | TOOTHBRUSH, MANUAL 76EFW | XIHE COMMERCE CO LTDCHINA |
| 12/22/2025 | BUR, DENTAL 76EJL | YAMMI LEONCHINA |
| 12/18/2025 | EXTENDED RANGE OF VISION INTRAOCULAR LENS 86POE | EXCELLENT HI-CAREINDIA |
| 12/18/2025 | KIT, FIRST AID, TALKING 80OVR | DN TANKS LLCCANADA |
| 12/18/2025 | KIT, FIRST AID, TALKING 80OVR | DN TANKS LLCCANADA |
| 12/18/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | STOCKX ASIA LIMITEDHONG KONG |
| 12/17/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/16/2025 | SYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL 90MUH | Midmark CorporationUNITED STA |
Related Violations
Other violations under the same legal section: 502(o), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 341?
341 is an FDA violation code that indicates: "It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).". 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 341?
According to FDA Import Refusal data, there have been 21657 import refusals issued for violation code 341, affecting 9991 unique firms.
When was the most recent refusal for violation 341?
The most recent import refusal for violation 341 was on December 31, 2025.
What products are commonly refused for violation 341?
Products commonly refused under violation 341 include: SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 341?
Violation code 341 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.