Violation Code: 226
FDA Violation
Charge Code: DEVICE GMP
Violation Details
- Violation Code (ASC ID)
- 226
- Charge Code
- DEVICE GMP
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
- Legal Section
- 501(h), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | HEALTHIUM MEDTECH LIMITED | Bangalore, INDIA | 10 |
| 2 | Vitalograph (Ireland), Ltd. | Ennis, IRELAND | 4 |
| 3 | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Hamburg, GERMANY | 3 |
| 4 | Nadir & Co. | Sialkot, PAKISTAN | 3 |
| 5 | Tinopal Surgical Corp. (Pvt) Ltd. | Sialkot, PAKISTAN | 2 |
| 6 | Bricon Technology GmbH | Wurmlingen, GERMANY | 1 |
| 7 | Eleonor Makey | Kharkov, UKRAINE | 1 |
| 8 | Convertors De Mexico | Juarez, MEXICO | 1 |
| 9 | Arrow Africa | Sandton, SOUTH AFRI | 1 |
| 10 | Glorious Mercantile Corp. Pvt. Ltd. | Sialkot, PAKISTAN | 1 |
| 11 | H & A Mui Enterprises, Inc. | Mississauga, CANADA | 1 |
| 12 | More Diagnostics | Los Osos, UNITED STA | 1 |
| 13 | Arriol International Corp. | Santo Domingo, DOMINICAN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/15/2012 | NEEDLE, HYPODERMIC, SINGLE LUMEN 80FMI | Arriol International Corp.DOMINICAN |
| 6/20/2012 | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) 78FFX | |
| 10/5/2011 | SUTURE, NONABSORBABLE 79GAO | |
| 10/5/2011 | SUTURE, NONABSORBABLE 79GAO | |
| 10/5/2011 | SUTURE, ABSORBABLE 79GAK | |
| 10/5/2011 | SUTURE, NONABSORBABLE 79GAO | |
| 10/5/2011 | SUTURE, ABSORBABLE 79GAK | |
| 10/5/2011 | SUTURE, NONABSORBABLE 79GAO | |
| 10/5/2011 | SUTURE, NONABSORBABLE 79GAO | |
| 10/5/2011 | SUTURE, ABSORBABLE 79GAK | |
| 10/5/2011 | SUTURE, NONABSORBABLE 79GAO | |
| 10/5/2011 | SUTURE, ABSORBABLE 79GAK | |
| 9/9/2011 | WHOLE BLOOD PLASMA, ANTIGEN, ANTISERUM, CONTROL 82DGQ | More DiagnosticsUNITED STA |
| 3/2/2011 | TRAY, SURGICAL 79LRP | Convertors De MexicoMEXICO |
| 4/23/2010 | FORCEPS, RONGEUR, SURGICAL 76EMH |
Frequently Asked Questions
What is FDA violation code 226?
226 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act. ". This violation is based on 501(h), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 226?
According to FDA Import Refusal data, there have been 30 import refusals issued for violation code 226, affecting 13 unique firms.
When was the most recent refusal for violation 226?
The most recent import refusal for violation 226 was on October 15, 2012.
What products are commonly refused for violation 226?
Products commonly refused under violation 226 include: NEEDLE, HYPODERMIC, SINGLE LUMEN, SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL), SUTURE, NONABSORBABLE, SUTURE, ABSORBABLE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 226?
Violation code 226 is based on 501(h), 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.