Suzhou Du Fa Medical Dressing Co., Ltd.
⚠️ Moderate Risk
FEI: 3003705121 • Suzhou, Jiangsu • CHINA
FEI Number
3003705121
Location
Suzhou, Jiangsu
Country
CHINAAddress
NO. 147-151 West Shihu Road, , Suzhou, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2009 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 4/28/2004 | 79EFQSPONGE, GAUZE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 4/28/2004 | 79EFQSPONGE, GAUZE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 4/28/2004 | 79EFQSPONGE, GAUZE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 4/28/2004 | 79EFQSPONGE, GAUZE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/22/2004 | 79EFQSPONGE, GAUZE | 290DE IMP GMP | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Suzhou Du Fa Medical Dressing Co., Ltd.'s FDA import refusal history?
Suzhou Du Fa Medical Dressing Co., Ltd. (FEI: 3003705121) has 6 FDA import refusal record(s) in our database, spanning from 1/22/2004 to 11/24/2009.
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 Du Fa Medical Dressing Co., Ltd.'s FEI number is 3003705121.
What types of violations has Suzhou Du Fa Medical Dressing Co., Ltd. received?
Suzhou Du Fa Medical Dressing 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 Du Fa Medical Dressing Co., Ltd. come from?
All FDA import refusal data for Suzhou Du Fa Medical Dressing 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.