Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd.
⚠️ Moderate Risk
FEI: 3008288202 • Yangzhou, Jiangsu • CHINA
FEI Number
3008288202
Location
Yangzhou, Jiangsu
Country
CHINAAddress
1 East Zhaizhuang Road Hangji, Hangji Town, Yangzhou, 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).
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 |
|---|---|---|---|
| 1/30/2013 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | New Orleans District Office (NOL-DO) | |
| 1/30/2013 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | New Orleans District Office (NOL-DO) | |
| 1/30/2013 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd.'s FDA import refusal history?
Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd. (FEI: 3008288202) has 3 FDA import refusal record(s) in our database, spanning from 1/30/2013 to 1/30/2013.
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. Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd.'s FEI number is 3008288202.
What types of violations has Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd. received?
Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd. has been cited for 2 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 Jiangsu Xinheyuan Plastic Daily Chemical Co.,Ltd. come from?
All FDA import refusal data for Jiangsu Xinheyuan Plastic Daily Chemical 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.