Suzhou Wugan Chemical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004365047 • Wujiang, Jiangsu • CHINA
FEI Number
3004365047
Location
Wujiang, Jiangsu
Country
CHINAAddress
Tuncan Town, , Wujiang, 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
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2010 | 61GDS48SULFADIAZINE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Detroit District Office (DET-DO) | |
| 5/26/2009 | 61GDS48SULFADIAZINE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | Detroit District Office (DET-DO) |
| 5/31/2007 | 61GCS48SULFADIAZINE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Suzhou Wugan Chemical Co., Ltd.'s FDA import refusal history?
Suzhou Wugan Chemical Co., Ltd. (FEI: 3004365047) has 3 FDA import refusal record(s) in our database, spanning from 5/31/2007 to 11/12/2010.
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. Suzhou Wugan Chemical Co., Ltd.'s FEI number is 3004365047.
What types of violations has Suzhou Wugan Chemical Co., Ltd. received?
Suzhou Wugan 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 Suzhou Wugan Chemical Co., Ltd. come from?
All FDA import refusal data for Suzhou Wugan 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.