Hubei Weikang Protective Products Co., Ltd.
⚠️ High Risk
FEI: 3005090771 • Xiantao, Hubei • CHINA
FEI Number
3005090771
Location
Xiantao, Hubei
Country
CHINAAddress
Gongqing Chuangye, Yewang Road; Industrial Zone, Xiantao, Hubei, 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).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2016 | 79BWPSHOE AND SHOE COVER, CONDUCTIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/28/2016 | 73KHAMASK, SCAVENGING | 3724DEVGMPS | Southwest Import District Office (SWI-DO) |
| 3/18/2016 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 3/18/2016 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 3/18/2016 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 2/8/2016 | 79FXXMASK, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/8/2016 | 79BWPSHOE AND SHOE COVER, CONDUCTIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/8/2016 | 80OEANON-SURGICAL ISOLATION GOWN | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 11/5/2015 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/5/2015 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/5/2015 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/5/2015 | 79FXXMASK, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 11/3/2015 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/30/2015 | 73KHAMASK, SCAVENGING | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Hubei Weikang Protective Products Co., Ltd.'s FDA import refusal history?
Hubei Weikang Protective Products Co., Ltd. (FEI: 3005090771) has 14 FDA import refusal record(s) in our database, spanning from 10/30/2015 to 5/24/2016.
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. Hubei Weikang Protective Products Co., Ltd.'s FEI number is 3005090771.
What types of violations has Hubei Weikang Protective Products Co., Ltd. received?
Hubei Weikang Protective Products Co., Ltd. has been cited for 3 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 Hubei Weikang Protective Products Co., Ltd. come from?
All FDA import refusal data for Hubei Weikang Protective Products 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.