Violation Code: 231
FDA Violation
Charge Code: LENS CERT
Violation Details
- Violation Code (ASC ID)
- 231
- Charge Code
- LENS CERT
- Description
- The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
- Legal Section
- 502(a), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | TAIZHOU PINXIN GLASSES CO., LTD | Taizhou, CHINA | 38 |
| 2 | LINHAISHI WANDA GLASSES FACTORY | LINHAI, CHINA | 23 |
| 3 | Borrion Great Enterprise Wenzhou | Wenzhou Zhejian, CHINA | 18 |
| 4 | Linhai City Qianbaidu Glasses Factory | Taizhou, CHINA | 15 |
| 5 | Great Yo Co., LTD | Yongkang City, TAIWAN | 13 |
| 6 | NEW ERA ENTERPRISE CO.,LTD. | Tainan City, TAIWAN | 12 |
| 7 | Wenzhou Lucheng Bright Glasses | Wenzhou, CHINA | 10 |
| 8 | Shuyu Co. Ltd. | Sabae, JAPAN | 10 |
| 9 | Japan Spectacles & Popular Optic | Osaka, JAPAN | 8 |
| 10 | Pilot Optics International Corp., Ltd., Wenzhou | Wenzhou, CHINA | 7 |
| 11 | Tazhou Meidiya Glasses Co., Ltd. | Taizhou, CHINA | 7 |
| 12 | Frame-Tec Co., Ltd | Daegu, SOUTH KORE | 7 |
| 13 | SHENZHEN GONBES TECHNOLOGY | CN, CHINA | 7 |
| 14 | Wenzhou Outlook Optical Co Ltd | Wenzhou, CHINA | 7 |
| 15 | Taizhou Hongfa Glasses Co., Ltd. | Taizhou, CHINA | 6 |
| 16 | Taizhou City Chuntian Glasses Co Ltd | Taizhou, CHINA | 6 |
| 17 | Luxottica Group S.P.A. | AGORDO, ITALY | 6 |
| 18 | DONGGUAN IALIN OPTICAL MFG. CO., LTD. | Dong-guan City, CHINA | 6 |
| 19 | Ywu Eixu Trading Co Ltd | Ywu Zhejang, CHINA | 6 |
| 20 | Safilo S.P.A | Padova, ITALY | 5 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY | |
| 1/6/2026 | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) 86HQY |
Related Violations
Other violations under the same legal section: 502(a), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 231?
231 is an FDA violation code that indicates: "The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.". This violation is based on 502(a), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 231?
According to FDA Import Refusal data, there have been 662 import refusals issued for violation code 231, affecting 350 unique firms.
When was the most recent refusal for violation 231?
The most recent import refusal for violation 231 was on January 6, 2026.
What products are commonly refused for violation 231?
Products commonly refused under violation 231 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 231?
Violation code 231 is based on 502(a), 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.