Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd.
⚠️ Moderate Risk
FEI: 3002623862 • Wuzhou, Guangxi Province • CHINA
FEI Number
3002623862
Location
Wuzhou, Guangxi Province
Country
CHINAAddress
Grand Creak Chengan, , Wuzhou, Guangxi Province, 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.
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).
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.
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 |
|---|---|---|---|
| 9/24/2013 | 62UAL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/24/2013 | 64HBL02GUAIFENESIN (EXPECTORANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/8/2004 | 64HBK02GUAIFENESIN (EXPECTORANT) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd.'s FDA import refusal history?
Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd. (FEI: 3002623862) has 3 FDA import refusal record(s) in our database, spanning from 1/8/2004 to 9/24/2013.
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. Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd.'s FEI number is 3002623862.
What types of violations has Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd. received?
Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd. 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 Wuzhou Shui Foo Cheung Pharmaceutical Corp., Ltd. come from?
All FDA import refusal data for Wuzhou Shui Foo Cheung Pharmaceutical Corp., 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.