Violation Code: 3905
FDA Violation
Charge Code: 3905
341
Total Refusals
83
Affected Firms
12/23/2025
Latest Case
7/21/2023
First Case
Violation Details
- Violation Code (ASC ID)
- 3905
- Charge Code
- 3905
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | UNION MEDICO APS | Copenhagen, DENMARK | 91 |
| 2 | NOGA MEDICAL PRODUCTS LTD. | Shlomi, ISRAEL | 48 |
| 3 | Aizu Olympus Co., Ltd. | Aizuwakamatsu, JAPAN | 30 |
| 4 | SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. | Weifang, CHINA | 12 |
| 5 | Shen Zhen As Tec Technology Co Ltd | Shenzhen, CHINA | 11 |
| 6 | WENZHOU DONGWU OPTICAL INSTRUMENT C | Wenzhou, CHINA | 10 |
| 7 | MEDITIME CO., LTD | Wonju, SOUTH KORE | 8 |
| 8 | NINGBO BAICHEN MEDICAL DEVICES CO., LTD | Ningbo, CHINA | 8 |
| 9 | JOYTECH HEALTHCARE CO. LTD. | Hangzhou, CHINA | 8 |
| 10 | Micro-Tech (Nanjing) Co., Ltd. | Nanjing, CHINA | 7 |
| 11 | BALT Extrusion SAS | Montmorency, FRANCE | 7 |
| 12 | Alcon Research LLC | Fort Worth, UNITED STA | 6 |
| 13 | Grand Work Plastic Products Co., Ltd. | Zanhuang City, CHINA | 6 |
| 14 | Wuhan Huawei Technology Co., Ltd. | Wuhan, CHINA | 4 |
| 15 | FUZHOU BORNI PHARMACEUTICAL SCITECH CO | Fuzhou, CHINA | 3 |
| 16 | Hong Qiangxing (Shen Zhen) Electronics Limited | Baoan District, CHINA | 3 |
| 17 | TaiDoc Technology Corporation | New Taipei City, TAIWAN | 3 |
| 18 | Wuhan Dimed Laser Technology Co., Ltd. | Wuhan, CHINA | 2 |
| 19 | Oscor Caribe, LLC | Santo Domingo, DOMINICAN | 2 |
| 20 | CRYOIQ AB | Onsala, SWEDEN | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | CATHETER, RETENTION TYPE, BALLOON 78EZL | |
| 12/23/2025 | CATHETER, STRAIGHT 78EZD | |
| 12/18/2025 | SLEEVE, LIMB, COMPRESSIBLE 74JOW | CAREMED SUPPLY, INC.TAIWAN |
| 12/10/2025 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 12/4/2025 | SYRINGE, PISTON 80FMF | Advance Medical Designs, Inc.UNITED STA |
| 12/4/2025 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | KOMENT SASCOLOMBIA |
| 12/2/2025 | PLASMODIUM SPP. DETECTION REAGENTS 83OAX | ABBOTT DIAGNOSTICS KOREA INCSOUTH KORE |
| 11/28/2025 | GENERAL PURPOSE REAGENT 88PPM | |
| 11/13/2025 | NEEDLE, ACUPUNCTURE, SINGLE USE 80MQX | Ktr Europe GmbhGERMANY |
| 11/6/2025 | LASER FOR PAIN THERAPY 84LLP | |
| 10/24/2025 | LAMP, INFRARED, THERAPEUTIC HEATING 89ILY | |
| 10/22/2025 | GLUCOSE OXIDASE, GLUCOSE 75CGA | |
| 10/22/2025 | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL 75CHH | |
| 10/22/2025 | THERMOMETER, ELECTRONIC, CLINICAL 80FLL | |
| 10/20/2025 | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) 77EOB |
Frequently Asked Questions
What is FDA violation code 3905?
3905 is an FDA violation code used during import inspections.
How many import refusals have been issued for violation 3905?
According to FDA Import Refusal data, there have been 341 import refusals issued for violation code 3905, affecting 83 unique firms.
When was the most recent refusal for violation 3905?
The most recent import refusal for violation 3905 was on December 23, 2025.
What products are commonly refused for violation 3905?
Products commonly refused under violation 3905 include: CATHETER, RETENTION TYPE, BALLOON, CATHETER, STRAIGHT, SLEEVE, LIMB, COMPRESSIBLE, LAMP, INFRARED, THERAPEUTIC HEATING, SYRINGE, PISTON. These products were refused entry because they did not meet FDA requirements.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.