Onbo Electronic (Shenzhen) Co., Ltd
⚠️ Moderate Risk
FEI: 3003010579 • Shenzhen, Guangdong • CHINA
FEI Number
3003010579
Location
Shenzhen, Guangdong
Country
CHINAAddress
No.138, Huasheng Road Langkou Community, Dalang Street, Longhua District, , Shenzhen, 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
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2019 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 8/12/2019 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 3/6/2015 | 74LDESTETHOSCOPE, MANUAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/6/2015 | 74LDESTETHOSCOPE, MANUAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/6/2015 | 74LDESTETHOSCOPE, MANUAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/28/2011 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 9/9/2010 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 9/9/2010 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Onbo Electronic (Shenzhen) Co., Ltd's FDA import refusal history?
Onbo Electronic (Shenzhen) Co., Ltd (FEI: 3003010579) has 8 FDA import refusal record(s) in our database, spanning from 9/9/2010 to 8/12/2019.
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. Onbo Electronic (Shenzhen) Co., Ltd's FEI number is 3003010579.
What types of violations has Onbo Electronic (Shenzhen) Co., Ltd received?
Onbo Electronic (Shenzhen) Co., Ltd has been cited for 4 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 Onbo Electronic (Shenzhen) Co., Ltd come from?
All FDA import refusal data for Onbo Electronic (Shenzhen) 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.