Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
⚠️ High Risk
FEI: 3010601992 • Huizhou, Guangdong • CHINA
FEI Number
3010601992
Location
Huizhou, Guangdong
Country
CHINAAddress
Zhongkai Hi-Tech Zone, Tangjiao Xingwang Street; Lilin Town, Huizhou, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 4/28/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 4/28/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 4/21/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 4/21/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 4/13/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 4/12/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/12/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 4/5/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 3/24/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 3/21/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd.'s FDA import refusal history?
Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. (FEI: 3010601992) has 11 FDA import refusal record(s) in our database, spanning from 3/21/2022 to 5/2/2022.
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. Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd.'s FEI number is 3010601992.
What types of violations has Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. received?
Wickimed (Huizhou) Medical Equipment Manufacturing 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 Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. come from?
All FDA import refusal data for Wickimed (Huizhou) Medical Equipment Manufacturing 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.