FOSHAN COXO MEDICAL INSTRUMENT CO. Ltd
⚠️ Moderate Risk
FEI: 3014953747 • Foshan, Guangdong • CHINA
FEI Number
3014953747
Location
Foshan, Guangdong
Country
CHINAAddress
Bldg 4, A, Guangdong New Light Source Industrial Base; District, Foshan, 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 7/10/2017 | 76DZIDRILL, BONE, POWERED | Division of Southeast Imports (DSEI) | |
| 6/4/2012 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76EGSHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is FOSHAN COXO MEDICAL INSTRUMENT CO. Ltd's FDA import refusal history?
FOSHAN COXO MEDICAL INSTRUMENT CO. Ltd (FEI: 3014953747) has 6 FDA import refusal record(s) in our database, spanning from 6/4/2012 to 7/10/2017.
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. FOSHAN COXO MEDICAL INSTRUMENT CO. Ltd's FEI number is 3014953747.
What types of violations has FOSHAN COXO MEDICAL INSTRUMENT CO. Ltd received?
FOSHAN COXO MEDICAL INSTRUMENT 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 FOSHAN COXO MEDICAL INSTRUMENT CO. Ltd come from?
All FDA import refusal data for FOSHAN COXO MEDICAL 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.