Violation Code: 3904
FDA Violation
Charge Code: 3904
369
Total Refusals
66
Affected Firms
1/7/2026
Latest Case
6/29/2023
First Case
Violation Details
- Violation Code (ASC ID)
- 3904
- Charge Code
- 3904
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | UNION MEDICO APS | Copenhagen, DENMARK | 182 |
| 2 | Aizu Olympus Co., Ltd. | Aizuwakamatsu, JAPAN | 30 |
| 3 | Shen Zhen As Tec Technology Co Ltd | Shenzhen, CHINA | 12 |
| 4 | WENZHOU DONGWU OPTICAL INSTRUMENT C | Wenzhou, CHINA | 10 |
| 5 | MEDITIME CO., LTD | Wonju, SOUTH KORE | 9 |
| 6 | JOYTECH HEALTHCARE CO. LTD. | Hangzhou, CHINA | 8 |
| 7 | NINGBO BAICHEN MEDICAL DEVICES CO., LTD | Ningbo, CHINA | 8 |
| 8 | Alcon Research LLC | Fort Worth, UNITED STA | 6 |
| 9 | EQUIDERM | Aulnay-Sous-Bois, FRANCE | 6 |
| 10 | P.T. Sankei Medical Industries | Serang, INDONESIA | 5 |
| 11 | Qingdao London Durex Co., Ltd. | Qingdao, CHINA | 5 |
| 12 | EMSRUN GROUP | Wuxi, CHINA | 4 |
| 13 | Wuhan Huawei Technology Co., Ltd. | Wuhan, CHINA | 4 |
| 14 | Kashmir Surgical Works | Ambala, INDIA | 3 |
| 15 | Wuhan Dimed Laser Technology Co., Ltd. | Wuhan, CHINA | 3 |
| 16 | TaiDoc Technology Corporation | New Taipei City, TAIWAN | 3 |
| 17 | Teoxane S.A. | Geneva, SWITZERLAN | 3 |
| 18 | Hilotherm Gmbh | Argenbuhl, GERMANY | 3 |
| 19 | Wuhan Lotuxs Technology Co., Ltd. | Wuhan, CHINA | 3 |
| 20 | Hong Qiangxing (Shen Zhen) Electronics Limited | Baoan District, CHINA | 3 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/7/2026 | ACID, HYALURONIC, INTRAARTICULAR 87MOZ | PHARMAMONDISGERMANY |
| 1/7/2026 | ACID, HYALURONIC, INTRAARTICULAR 87MOZ | PHARMAMONDISGERMANY |
| 1/7/2026 | ACID, HYALURONIC, INTRAARTICULAR 87MOZ | PHARMAMONDISGERMANY |
| 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 | POWERED LASER SURGICAL INSTRUMENTS 79GEX | |
| 12/4/2025 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | KOMENT SASCOLOMBIA |
| 11/13/2025 | NEEDLE, ACUPUNCTURE, SINGLE USE 80MQX | Ktr Europe GmbhGERMANY |
| 11/6/2025 | POWERED LASER SURGICAL INSTRUMENTS 79GEX | |
| 11/6/2025 | LASER FOR PAIN THERAPY 84LLP | |
| 10/29/2025 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | GMP Medicare Sdn Bhd(F25)MALAYSIA |
| 10/29/2025 | GLOVE, PATIENT EXAMINATION, POLY 80LZA | GMP Medicare Sdn Bhd(F25)MALAYSIA |
| 10/22/2025 | GLUCOSE OXIDASE, GLUCOSE 75CGA |
Frequently Asked Questions
What is FDA violation code 3904?
3904 is an FDA violation code used during import inspections.
How many import refusals have been issued for violation 3904?
According to FDA Import Refusal data, there have been 369 import refusals issued for violation code 3904, affecting 66 unique firms.
When was the most recent refusal for violation 3904?
The most recent import refusal for violation 3904 was on January 7, 2026.
What products are commonly refused for violation 3904?
Products commonly refused under violation 3904 include: ACID, HYALURONIC, INTRAARTICULAR, CATHETER, RETENTION TYPE, BALLOON, CATHETER, STRAIGHT. 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.