Violation Code: 3741
FDA Violation
Charge Code: FRNMFGREG
Violation Details
- Violation Code (ASC ID)
- 3741
- Charge Code
- FRNMFGREG
- Description
- The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
- Legal Section
- 510(i); 801(o)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Laboratoires Clarins | Pontoise, FRANCE | 40 |
| 2 | Fu Sung Pharmaceutaical Works | Unknown, CHINA | 36 |
| 3 | Parfums Christian Dior | Paris, FRANCE | 25 |
| 4 | Clarins | Neuilly Sur Seine, FRANCE | 20 |
| 5 | Mineralbio Co Ltd | Seongnam, SOUTH KORE | 20 |
| 6 | DK Innovision Co., Ltd | Cheonan, SOUTH KORE | 18 |
| 7 | Agfa Healthcare | Unterschleisheim, GERMANY | 18 |
| 8 | Juih Chau Co Ltd | Tainan, TAIWAN | 17 |
| 9 | The Estee Lauder Inc. | Melville, UNITED STA | 14 |
| 10 | Clarins S.A | Grand Bahama Island, BAHAMAS | 13 |
| 11 | Chanel Products | Neuilly Sur Seine CEDEX, FRANCE | 12 |
| 12 | Sesderma, SL | Rafelbunol, SPAIN | 12 |
| 13 | Jencare Skin Farm | Kingston, JAMAICA | 11 |
| 14 | Ks Lye Apparelglobal Co., Ltd | Suzhou, CHINA | 11 |
| 15 | Ottica Meloni SAS | Rome, ITALY | 10 |
| 16 | Labora S.R.O. | Tepla, CZECH REPU | 10 |
| 17 | Ever Eyewear Co., Ltd | Zhenjiang, CHINA | 10 |
| 18 | ZHEJIANG OUTLOOK EYEWEAR CO LTD | Wenzhoush, CHINA | 10 |
| 19 | DONGGUAN IALIN OPTICAL MFG. CO., LTD. | Dong-guan City, CHINA | 10 |
| 20 | Wenzhou Union Eyew | Wenzhou, CHINA | 10 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/2/2014 | NEEDLE, SPINAL, SHORT TERM 80MIA | Becton Dickinson & CompanyUNITED STA |
| 6/2/2014 | CONNECTOR, CATHETER 79GCD | Becton Dickinson & CompanyUNITED STA |
| 6/2/2014 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | Becton Dickinson & CompanyUNITED STA |
| 6/2/2014 | SOURCE, CARRIER, FIBEROPTIC LIGHT 77EQH | Baxter Healthcare CorporationUNITED STA |
| 6/2/2014 | OPHTHALMOSCOPE, BATTERY-POWERED 86HLJ | Baxter Healthcare CorporationUNITED STA |
| 3/5/2014 | BENOXINATE HCL (ANESTHETIC) 60QCS55 | Siegfried Evionnaz SASWITZERLAN |
| 3/5/2014 | BENOXINATE HCL (ANESTHETIC) 60QCS55 | Siegfried Evionnaz SASWITZERLAN |
| 3/5/2014 | BENOXINATE HCL (ANESTHETIC) 60QCS55 | Siegfried Evionnaz SASWITZERLAN |
| 3/5/2014 | BUPIVACAINE HYDROCHLORIDE (ANESTHETIC) 60QCS79 | Siegfried Evionnaz SASWITZERLAN |
| 3/5/2014 | BUPIVACAINE (ANESTHETIC) 60QCS30 | Siegfried Evionnaz SASWITZERLAN |
| 2/28/2014 | SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE 79FMK | East Trading CoSOUTH KORE |
| 2/24/2014 | SAW, PNEUMATICALLY POWERED 79KFK | Stryker CorporationUNITED STA |
| 2/24/2014 | URETEROSCOPE 78FGB | Olympus Corporation of the AmericasUNITED STA |
| 2/10/2014 | ANTI-TUSSIVE/COLD N.E.C. 62UBF99 | |
| 2/10/2014 | ANTI-TUSSIVE/COLD N.E.C. 62UBF99 |
Frequently Asked Questions
What is FDA violation code 3741?
3741 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.". This violation is based on 510(i); 801(o) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3741?
According to FDA Import Refusal data, there have been 1103 import refusals issued for violation code 3741, affecting 457 unique firms.
When was the most recent refusal for violation 3741?
The most recent import refusal for violation 3741 was on June 2, 2014.
What products are commonly refused for violation 3741?
Products commonly refused under violation 3741 include: NEEDLE, SPINAL, SHORT TERM, CONNECTOR, CATHETER, NEEDLE, HYPODERMIC, SINGLE LUMEN, SOURCE, CARRIER, FIBEROPTIC LIGHT, OPHTHALMOSCOPE, BATTERY-POWERED. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3741?
Violation code 3741 is based on 510(i); 801(o) 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.