Violation Code: 123
FDA Violation
Charge Code: BANNED
Violation Details
- Violation Code (ASC ID)
- 123
- Charge Code
- BANNED
- Description
- The article appears to be a banned device.
- Legal Section
- 501(g), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Siemens Healthcare Diagnostics Inc | Elkhart, UNITED STA | 2 |
| 2 | Danamedic Aps | Kgs. Lyngby, DENMARK | 1 |
| 3 | Roche Diagnostics Operations, Inc. | Indianapolis, UNITED STA | 1 |
| 4 | Max-Unite Co.Ltd | Zhongshan, CHINA | 1 |
| 5 | Better Breathing Devices Pty Ltd | Tweed Heads South, AUSTRALIA | 1 |
| 6 | Johnson And Johnson (Ireland) Ltd. | Dublin 24, IRELAND | 1 |
| 7 | 1800 Contact Lenses | Seattle, UNITED STA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/13/2023 | PERCUSSOR, POWERED-ELECTRIC 73BYI | Better Breathing Devices Pty LtdAUSTRALIA |
| 12/18/2012 | LASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95RES | Max-Unite Co.LtdCHINA |
| 6/19/2012 | EXTENDER, PENILE, MECHANICAL 78NHU | Danamedic ApsDENMARK |
| 10/18/2011 | DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION 83JTO | Roche Diagnostics Operations, Inc.UNITED STA |
| 10/18/2011 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | |
| 2/1/2006 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | 1800 Contact LensesUNITED STA |
| 12/2/2004 | GLUCOSE OXIDASE, GLUCOSE 75CGA | Siemens Healthcare Diagnostics IncUNITED STA |
| 12/2/2004 | GLUCOSE OXIDASE, GLUCOSE 75CGA | Siemens Healthcare Diagnostics IncUNITED STA |
Frequently Asked Questions
What is FDA violation code 123?
123 is an FDA violation code that indicates: "The article appears to be a banned device.". This violation is based on 501(g), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 123?
According to FDA Import Refusal data, there have been 8 import refusals issued for violation code 123, affecting 7 unique firms.
When was the most recent refusal for violation 123?
The most recent import refusal for violation 123 was on November 13, 2023.
What products are commonly refused for violation 123?
Products commonly refused under violation 123 include: PERCUSSOR, POWERED-ELECTRIC, LASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS, EXTENDER, PENILE, MECHANICAL, DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION, LENSES, SOFT CONTACT, DAILY WEAR. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 123?
Violation code 123 is based on 501(g), 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.