Violation Code: 235
FDA Violation
Charge Code: NOT IMPACT
Violation Details
- Violation Code (ASC ID)
- 235
- Charge Code
- NOT IMPACT
- Description
- The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
- Legal Section
- 501(c), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Wenzhou Aishi Optical Industry Co., Ltd. | Wenzhou, CHINA | 175 |
| 2 | TAIZHOU PINXIN GLASSES CO., LTD | Taizhou, CHINA | 94 |
| 3 | LINHAISHI WANDA GLASSES FACTORY | LINHAI, CHINA | 66 |
| 4 | MIDI | Fukui, JAPAN | 36 |
| 5 | Premier Optical Mfy. (ShenZhen) Co., Limited | Shenzhen, CHINA | 34 |
| 6 | Cartier | Zurich, SWITZERLAN | 29 |
| 7 | Luxottica North Europe | St. ALBANS, UNITED KIN | 27 |
| 8 | Everjoy Asia Ltd | Hong Kong, HONG KONG | 24 |
| 9 | Linhai City Qianbaidu Glasses Factory | Taizhou, CHINA | 24 |
| 10 | Luxottica Group S.P.A. | AGORDO, ITALY | 23 |
| 11 | Coastal Contacts Inc. | Vancouver, CANADA | 22 |
| 12 | Maui Jim, Inc. | Peoria, UNITED STA | 21 |
| 13 | Duty Free Air and Ship Supply (DFASS) | Miami, UNITED STA | 21 |
| 14 | NEW ERA ENTERPRISE CO.,LTD. | Tainan City, TAIWAN | 20 |
| 15 | DONGGUAN IALIN OPTICAL MFG. CO., LTD. | Dong-guan City, CHINA | 17 |
| 16 | Tazhou Meidiya Glasses Co., Ltd. | Taizhou, CHINA | 15 |
| 17 | Taizhou Hongfa Glasses Co., Ltd. | Taizhou, CHINA | 15 |
| 18 | Lanson Optical Co., Ltd. | Wenzhou, CHINA | 15 |
| 19 | Wenzhou Outlook Optical Co Ltd | Wenzhou, CHINA | 15 |
| 20 | Pilot Optics International Corp., Ltd., Wenzhou | Wenzhou, CHINA | 15 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/31/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 12/5/2025 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY |
Related Violations
Other violations under the same legal section: 501(c), 801(a)(3); ADULTERATION
| Code | Charge Code | Cases |
|---|---|---|
| 331 | DR QUALITC | 294 |
Frequently Asked Questions
What is FDA violation code 235?
235 is an FDA violation code that indicates: "The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.". This violation is based on 501(c), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 235?
According to FDA Import Refusal data, there have been 2590 import refusals issued for violation code 235, affecting 1220 unique firms.
When was the most recent refusal for violation 235?
The most recent import refusal for violation 235 was on December 31, 2025.
What products are commonly refused for violation 235?
Products commonly refused under violation 235 include: SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 235?
Violation code 235 is based on 501(c), 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.