Jiangxi Hemei Pharmaceutical Co., Ltd
⚠️ High Risk
FEI: 3030186607 • Yichun, Jiangxi • CHINA
FEI Number
3030186607
Location
Yichun, Jiangxi
Country
CHINAAddress
4th Floor, Building 1956, Phase III, Zhangjiashan Medical Incubation Park, Zhangshu, Yichun, Jiangxi, 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
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.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 61WAY31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2025 | 66BBD44NICOTINE DELIVERY SYSTEM | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/21/2025 | 66BDY44NICOTINE DELIVERY SYSTEM | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Jiangxi Hemei Pharmaceutical Co., Ltd's FDA import refusal history?
Jiangxi Hemei Pharmaceutical Co., Ltd (FEI: 3030186607) has 3 FDA import refusal record(s) in our database, spanning from 10/21/2025 to 12/9/2025.
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. Jiangxi Hemei Pharmaceutical Co., Ltd's FEI number is 3030186607.
What types of violations has Jiangxi Hemei Pharmaceutical Co., Ltd received?
Jiangxi Hemei Pharmaceutical 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 Jiangxi Hemei Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Jiangxi Hemei Pharmaceutical 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.