Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd.
⚠️ Moderate Risk
FEI: 1000198176 • Shenzhen • CHINA
FEI Number
1000198176
Location
Shenzhen
Country
CHINAAddress
33-35 Second Industrial District, Kwun Lan Town, Po On Yuen, Shenzhen, , China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2019 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 5/11/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 6/27/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northern Border Imports (DNBI) |
| 2/16/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd.'s FDA import refusal history?
Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd. (FEI: 1000198176) has 4 FDA import refusal record(s) in our database, spanning from 2/16/2016 to 1/23/2019.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd.'s FEI number is 1000198176.
What types of violations has Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd. received?
Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd. come from?
All FDA import refusal data for Sunwha Kiang Optical Mfg. (Shenzhen) Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.