Changzhou Kaiyuan Garments Co. Ltd.
✅ Low Risk
FEI: 1000384161 • Changzhou, Jiangsu • CHINA
FEI Number
1000384161
Location
Changzhou, Jiangsu
Country
CHINAAddress
Wu Jin Xian,Chang, Yuncun; Wujinxiang, Changzhou, Jiangsu, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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 |
|---|---|---|---|
| 10/1/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/1/2015 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/1/2015 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Changzhou Kaiyuan Garments Co. Ltd.'s FDA import refusal history?
Changzhou Kaiyuan Garments Co. Ltd. (FEI: 1000384161) has 3 FDA import refusal record(s) in our database, spanning from 10/1/2015 to 10/1/2015.
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. Changzhou Kaiyuan Garments Co. Ltd.'s FEI number is 1000384161.
What types of violations has Changzhou Kaiyuan Garments Co. Ltd. received?
Changzhou Kaiyuan Garments Co. Ltd. has been cited for 1 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 Changzhou Kaiyuan Garments Co. Ltd. come from?
All FDA import refusal data for Changzhou Kaiyuan Garments 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.