Violation Code: 3081
FDA Violation
Charge Code: INVDEVICE
Violation Details
- Violation Code (ASC ID)
- 3081
- Charge Code
- INVDEVICE
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
- Legal Section
- 501(i), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Cardionics SA | Sint-Jans-Molenbeek, BELGIUM | 9 |
| 2 | Becton Dickinson Infusion Therapy UK | Swindon, UNITED KIN | 6 |
| 3 | Cardston Medical Research | New Westminster, CANADA | 4 |
| 4 | Natus Neurology Inc | Middleton, UNITED STA | 3 |
| 5 | Edwards Lifesciences Ag | Rio Haina, DOMINICAN | 3 |
| 6 | Pq Bypass | Sunnyvale, UNITED STA | 2 |
| 7 | Contacare Ophthalmics & Diagnostics | Dabhasa, INDIA | 1 |
| 8 | B & C Group Nv/Sa | Louvain-la-Neuve, BELGIUM | 1 |
| 9 | Anti Aging Solutions Inc. | Etobicoke, CANADA | 1 |
| 10 | Cardinal Health Mexico 244 S de RL de CV | Juarez, MEXICO | 1 |
| 11 | Baxter Productos Medicos, Ltda. | Cartago, COSTA RICA | 1 |
| 12 | CareFusion Gmbh | Hochberg, GERMANY | 1 |
| 13 | Brain Products Gmb | Gilching, GERMANY | 1 |
| 14 | Elexxion Ag | Singen (Hohentwiel), GERMANY | 1 |
| 15 | Electrocore Pty Ltd | New South Wales, AUSTRALIA | 1 |
| 16 | Biomatalante | Vigneux-De-Bretagne, FRANCE | 1 |
| 17 | FIAB spa | Vicchio, ITALY | 1 |
| 18 | Fresenius Kabi AG | Bad Homburg, GERMANY | 1 |
| 19 | Hansol Medical | Paju-si, SOUTH KORE | 1 |
| 20 | AYSENS GRUPP | Moscow, RUSSIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/3/2023 | INTRODUCER, SYRINGE NEEDLE 80KZH | |
| 11/17/2021 | LASER, DENTAL, SOFT TISSUE 76NVK | Elexxion AgGERMANY |
| 9/29/2021 | SPLINT, INTRANASAL SEPTAL 77LYA | AYSENS GRUPPRUSSIA |
| 9/30/2019 | ELECTROCARDIOGRAPH 74DPS | REALTIME TECHNOLOGIES LTDIRELAND |
| 9/4/2019 | BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED) 80CBC | OWLSTONE MEDICAL LTDUNITED KIN |
| 11/16/2018 | DEVICE, TRANSCATHETER CARDIAC OCCLUSION 74MLV | Abbott Medical Costa Rica LtdaCOSTA RICA |
| 11/9/2018 | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE 78NYV | VIBRANT LTDISRAEL |
| 5/2/2018 | STRABISMUS DETECTION DEVICE 86PMW | |
| 3/23/2018 | INFUSOR, PRESSURE, FOR I.V. BAGS 80KZD | Fresenius Kabi AGGERMANY |
| 4/22/2016 | DEVICE, HEMOSTASIS, VASCULAR 74MGB | |
| 3/24/2016 | DEVICE, BIOFEEDBACK 84HCC | Nirx Medical TechnologiesGERMANY |
| 12/21/2015 | TOOTHBRUSH, MANUAL 76EFW | The Procter & Gamble CoUNITED STA |
| 12/21/2015 | CLEANSER, DENTURE, OTC 76EFT | O-PacITALY |
| 10/1/2015 | GRAFT, BYPASS, CORONARY ARTERY 74NAV | Pq BypassUNITED STA |
| 10/1/2015 | DEVICE, ANASTOMOTIC, MICROVASCULAR 74MVR | Pq BypassUNITED STA |
Frequently Asked Questions
What is FDA violation code 3081?
3081 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)". This violation is based on 501(i), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3081?
According to FDA Import Refusal data, there have been 68 import refusals issued for violation code 3081, affecting 47 unique firms.
When was the most recent refusal for violation 3081?
The most recent import refusal for violation 3081 was on April 3, 2023.
What products are commonly refused for violation 3081?
Products commonly refused under violation 3081 include: INTRODUCER, SYRINGE NEEDLE, LASER, DENTAL, SOFT TISSUE, SPLINT, INTRANASAL SEPTAL, ELECTROCARDIOGRAPH, BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3081?
Violation code 3081 is based on 501(i), 801(a)(3); ADULTERATION 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.