Panasonic Electric Works Wanbao
⚠️ Moderate Risk
FEI: 3006704335 • Guangdong • CHINA
FEI Number
3006704335
Location
Guangdong
Country
CHINAAddress
Wanbao Base, Shi Guang Road, , Pan Yu, Guangdong, , 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 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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2012 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 10/26/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 8/25/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 7/12/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/9/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/17/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/12/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/25/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/11/2011 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Florida District Office (FLA-DO) | |
| 12/28/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/16/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 9/15/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 8/3/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/1/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 5/28/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Panasonic Electric Works Wanbao's FDA import refusal history?
Panasonic Electric Works Wanbao (FEI: 3006704335) has 16 FDA import refusal record(s) in our database, spanning from 5/20/2010 to 8/21/2012.
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. Panasonic Electric Works Wanbao's FEI number is 3006704335.
What types of violations has Panasonic Electric Works Wanbao received?
Panasonic Electric Works Wanbao 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 Panasonic Electric Works Wanbao come from?
All FDA import refusal data for Panasonic Electric Works Wanbao 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.