Wenzhou Bokang Instrument Co., Ltd.
⚠️ Moderate Risk
FEI: 3003958564 • Wenzhou, Zhejiang • CHINA
FEI Number
3003958564
Location
Wenzhou, Zhejiang
Country
CHINAAddress
In Longwan, No. 1500 Haibin Street; Zhejiang Prov, Wenzhou, Zhejiang, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/30/2019 | 74DXQCUFF, BLOOD-PRESSURE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 4/29/2019 | 74DXQCUFF, BLOOD-PRESSURE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 4/4/2019 | 74DXQCUFF, BLOOD-PRESSURE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 3/19/2019 | 74DXQCUFF, BLOOD-PRESSURE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 3/15/2019 | 74DXQCUFF, BLOOD-PRESSURE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 3/12/2018 | 74DXQCUFF, BLOOD-PRESSURE | Division of Southeast Imports (DSEI) | |
| 2/27/2018 | 74DXQCUFF, BLOOD-PRESSURE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/28/2017 | 74DXQCUFF, BLOOD-PRESSURE | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 12/7/2011 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wenzhou Bokang Instrument Co., Ltd.'s FDA import refusal history?
Wenzhou Bokang Instrument Co., Ltd. (FEI: 3003958564) has 9 FDA import refusal record(s) in our database, spanning from 12/7/2011 to 4/30/2019.
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. Wenzhou Bokang Instrument Co., Ltd.'s FEI number is 3003958564.
What types of violations has Wenzhou Bokang Instrument Co., Ltd. received?
Wenzhou Bokang Instrument Co., Ltd. has been cited for 5 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 Wenzhou Bokang Instrument Co., Ltd. come from?
All FDA import refusal data for Wenzhou Bokang Instrument 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.