Xiamen Chingsong Optical Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3003878632 • Xiamen, Fujian • CHINA
FEI Number
3003878632
Location
Xiamen, Fujian
Country
CHINAAddress
38 Xingbei Road, Xinglin District, Xiamen, Fujian, 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.
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 |
|---|---|---|---|
| 9/24/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Detroit District Office (DET-DO) |
| 6/7/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 4/10/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
| 4/10/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
| 4/10/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
| 4/10/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Xiamen Chingsong Optical Industrial Co., Ltd.'s FDA import refusal history?
Xiamen Chingsong Optical Industrial Co., Ltd. (FEI: 3003878632) has 6 FDA import refusal record(s) in our database, spanning from 4/10/2012 to 9/24/2014.
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. Xiamen Chingsong Optical Industrial Co., Ltd.'s FEI number is 3003878632.
What types of violations has Xiamen Chingsong Optical Industrial Co., Ltd. received?
Xiamen Chingsong Optical Industrial Co., Ltd. has been cited for 3 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 Xiamen Chingsong Optical Industrial Co., Ltd. come from?
All FDA import refusal data for Xiamen Chingsong Optical Industrial 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.