Yangzhou Huashu Winsome Pharmacy Co., Ltd.
⚠️ Moderate Risk
FEI: 3003290702 • Yangzhou, Jiangsu • CHINA
FEI Number
3003290702
Location
Yangzhou, Jiangsu
Country
CHINAAddress
NO. 2 Road Jiangdu Economy, Jiangdou, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/3/2006 | 56ECR22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/11/2004 | 25QGN07MUSHROOM, CHANTERELLE, PIECES AND STEMS, SLICED | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 8/11/2004 | 24TGN38FERN, BRACKEN (LEAF & STEM VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 8/11/2004 | 39AGN08MIXED VEGETABLE SALAD (WITH DRESSING) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 8/11/2004 | 24TGN38FERN, BRACKEN (LEAF & STEM VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 8/11/2004 | 25JGN22BURDOCK, GOBO (ROOT & TUBER VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 8/11/2004 | 25JGN18LOTUS ROOT (ROOT & TUBER VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 8/11/2004 | 25JGN18LOTUS ROOT (ROOT & TUBER VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Yangzhou Huashu Winsome Pharmacy Co., Ltd.'s FDA import refusal history?
Yangzhou Huashu Winsome Pharmacy Co., Ltd. (FEI: 3003290702) has 8 FDA import refusal record(s) in our database, spanning from 8/11/2004 to 3/3/2006.
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. Yangzhou Huashu Winsome Pharmacy Co., Ltd.'s FEI number is 3003290702.
What types of violations has Yangzhou Huashu Winsome Pharmacy Co., Ltd. received?
Yangzhou Huashu Winsome Pharmacy 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 Yangzhou Huashu Winsome Pharmacy Co., Ltd. come from?
All FDA import refusal data for Yangzhou Huashu Winsome Pharmacy 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.