Sinochem Jiangsu
⚠️ Moderate Risk
FEI: 3004060322 • Nantong, Jiangsu • CHINA
FEI Number
3004060322
Location
Nantong, Jiangsu
Country
CHINAAddress
(M), 49 Qingnianlu; Chongchuan, Nantong, Jiangsu, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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 |
|---|---|---|---|
| 10/26/2012 | 54FCS82COCA LEAVES (HERBAL & BOTANICALS, NOT TEAS) | 2120UNSFDIETSP | Atlanta District Office (ATL-DO) |
| 2/22/2007 | 66SKS40INOSITOL NIACINATE (VASODILATOR) | New York District Office (NYK-DO) | |
| 5/18/2005 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sinochem Jiangsu's FDA import refusal history?
Sinochem Jiangsu (FEI: 3004060322) has 3 FDA import refusal record(s) in our database, spanning from 5/18/2005 to 10/26/2012.
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. Sinochem Jiangsu's FEI number is 3004060322.
What types of violations has Sinochem Jiangsu received?
Sinochem Jiangsu has been cited for 4 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 Sinochem Jiangsu come from?
All FDA import refusal data for Sinochem Jiangsu 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.