Nanjing Hanxin Pharmaceutical Technology Co., Ltd.
⚠️ High Risk
FEI: 3015142388 • Nanjing, Jiangsu • CHINA
FEI Number
3015142388
Location
Nanjing, Jiangsu
Country
CHINAAddress
Building C5, No. 9 Weidi Road, Xianlin University Town, Xianlin Street, Qixia, Nanjing, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2025 | 64RCS99HORMONE N.E.C. | 71NO LICENSE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Nanjing Hanxin Pharmaceutical Technology Co., Ltd.'s FDA import refusal history?
Nanjing Hanxin Pharmaceutical Technology Co., Ltd. (FEI: 3015142388) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2025 to 12/23/2025.
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. Nanjing Hanxin Pharmaceutical Technology Co., Ltd.'s FEI number is 3015142388.
What types of violations has Nanjing Hanxin Pharmaceutical Technology Co., Ltd. received?
Nanjing Hanxin Pharmaceutical Technology 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 Nanjing Hanxin Pharmaceutical Technology Co., Ltd. come from?
All FDA import refusal data for Nanjing Hanxin Pharmaceutical Technology 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.