Jiangxi Medicines & Health Products I/E Corp.
⚠️ Moderate Risk
FEI: 3001697840 • Nanchang, Jiangxi • CHINA
FEI Number
3001697840
Location
Nanchang, Jiangxi
Country
CHINAAddress
Foreign Trade Bldg., No. 200 Zhan Qian West Rd, Nanchang, Jiangxi, 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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2006 | 79EFQSPONGE, GAUZE | New York District Office (NYK-DO) | |
| 2/9/2005 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 2/25/2003 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Jiangxi Medicines & Health Products I/E Corp.'s FDA import refusal history?
Jiangxi Medicines & Health Products I/E Corp. (FEI: 3001697840) has 3 FDA import refusal record(s) in our database, spanning from 2/25/2003 to 6/26/2006.
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 Medicines & Health Products I/E Corp.'s FEI number is 3001697840.
What types of violations has Jiangxi Medicines & Health Products I/E Corp. received?
Jiangxi Medicines & Health Products I/E Corp. has been cited for 5 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 Medicines & Health Products I/E Corp. come from?
All FDA import refusal data for Jiangxi Medicines & Health Products I/E Corp. 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.