Violation Code: 289
FDA Violation
Charge Code: RECORDS
Violation Details
- Violation Code (ASC ID)
- 289
- Charge Code
- RECORDS
- Description
- The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
- Legal Section
- 502(t), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | AMO Puerto Rico Manufacturing, Inc. | Anasco, UNITED STA | 1 |
| 2 | Instrumek B.V. | Schiedam, NETHERLAND | 1 |
| 3 | Ningbo Ningshing Group Corp | Ningbo, CHINA | 1 |
| 4 | Madespa S.A. | Toledo, SPAIN | 1 |
| 5 | Shanghai Intco International Trading Co., Ltd. | Pudongxin, CHINA | 1 |
| 6 | Medical Econet | Seoul, SOUTH KORE | 1 |
| 7 | Taizhou Zhengda Optical Co., Ltd. | Taizhou, CHINA | 1 |
| 8 | Eltek Instrument (Pvt) Ltd. | Sialkot, PAKISTAN | 1 |
| 9 | Huqiu Imaging Tech | Suzhou, CHINA | 1 |
| 10 | Qingdao Mehel Int'L Trading Co Ltd | Qingdao, CHINA | 1 |
| 11 | Hk Boran Tech Tdg Co | Kwun Tong, HONG KONG | 1 |
| 12 | Vemed | Giesen, GERMANY | 1 |
| 13 | JINAN ARTSIGN SCIENCE & TECHNOLO | Jinan, CHINA | 1 |
| 14 | DUPLEX INTERNATIONAL TRADING LIMITED | Hong Kong, HONG KONG | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/5/2024 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | DUPLEX INTERNATIONAL TRADING LIMITEDHONG KONG |
| 9/1/2016 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 6/21/2016 | LASER MARKER OR ENGRAVER 95RHK | |
| 2/4/2013 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 9/11/2012 | SYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC 90JAC | Huqiu Imaging TechCHINA |
| 5/8/2012 | CABINET, X-RAY SYSTEM 90MWP | VemedGERMANY |
| 11/10/2010 | DEVICE, GENERAL MEDICAL 80LDQ | Hk Boran Tech Tdg CoHONG KONG |
| 9/3/2010 | CEMENT, DENTAL 76EMA | Madespa S.A.SPAIN |
| 8/28/2009 | SCISSORS, GENERAL USE, SURGICAL 79LRW | Eltek Instrument (Pvt) Ltd.PAKISTAN |
| 8/17/2009 | POWERED LASER SURGICAL INSTRUMENTS 79GEX | AMO Puerto Rico Manufacturing, Inc.UNITED STA |
| 10/22/2007 | FETAL DOPPLER ULTRASOUND 85LXE | |
| 2/6/2007 | SYSTEM, X-RAY, MOBILE 90IZL | Medical EconetSOUTH KORE |
| 3/11/2003 | ORTHOPEDIC IMPLANT MATERIAL 87MOO | Instrumek B.V.NETHERLAND |
| 4/11/2002 | GLOVE, PATIENT EXAMINATION, LATEX 80LYY |
Frequently Asked Questions
What is FDA violation code 289?
289 is an FDA violation code that indicates: "The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.". This violation is based on 502(t), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 289?
According to FDA Import Refusal data, there have been 14 import refusals issued for violation code 289, affecting 14 unique firms.
When was the most recent refusal for violation 289?
The most recent import refusal for violation 289 was on April 5, 2024.
What products are commonly refused for violation 289?
Products commonly refused under violation 289 include: MASSAGER, THERAPEUTIC, ELECTRIC, SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE), LASER MARKER OR ENGRAVER, SYSTEM, X-RAY, FILM MARKING, RADIOGRAPHIC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 289?
Violation code 289 is based on 502(t), 801(a)(3); MISBRANDING 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.