Egens Biotechnology Co. Ltd.
✅ Low Risk
FEI: 3010648873 • Nantong, Jiangsu • CHINA
FEI Number
3010648873
Location
Nantong, Jiangsu
Country
CHINAAddress
NO 12 No15 Building, No.1692 Xinghu Ave, , Nantong, 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 |
|---|---|---|---|
| 4/20/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 4/20/2015 | 91NGETEST, LUTEINIZING HORMONE (LH), OVER THE COUNTER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 4/20/2015 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Egens Biotechnology Co. Ltd.'s FDA import refusal history?
Egens Biotechnology Co. Ltd. (FEI: 3010648873) has 3 FDA import refusal record(s) in our database, spanning from 4/20/2015 to 4/20/2015.
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. Egens Biotechnology Co. Ltd.'s FEI number is 3010648873.
What types of violations has Egens Biotechnology Co. Ltd. received?
Egens Biotechnology 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 Egens Biotechnology Co. Ltd. come from?
All FDA import refusal data for Egens Biotechnology 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.