Shenzhen Ye Jun Enterprise Co.
⚠️ Moderate Risk
FEI: 3005990481 • Shenzhen, Guangdong • CHINA
FEI Number
3005990481
Location
Shenzhen, Guangdong
Country
CHINAAddress
Shenhua Commercial Bldg. Room 2608 Fl., 26;Honglixilu Xiangli Huayuan; Futian, Shenzhen, Guangdong, 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 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/26/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New England District Office (NWE-DO) |
| 12/26/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New England District Office (NWE-DO) |
| 12/26/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New England District Office (NWE-DO) |
| 12/26/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Shenzhen Ye Jun Enterprise Co.'s FDA import refusal history?
Shenzhen Ye Jun Enterprise Co. (FEI: 3005990481) has 4 FDA import refusal record(s) in our database, spanning from 12/26/2012 to 12/26/2012.
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. Shenzhen Ye Jun Enterprise Co.'s FEI number is 3005990481.
What types of violations has Shenzhen Ye Jun Enterprise Co. received?
Shenzhen Ye Jun Enterprise Co. 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 Shenzhen Ye Jun Enterprise Co. come from?
All FDA import refusal data for Shenzhen Ye Jun Enterprise Co. 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.