Quadrep Electronies(C)Ltd.
⚠️ Moderate Risk
FEI: 3008362718 • Shenzhen, Guangdong • CHINA
FEI Number
3008362718
Location
Shenzhen, Guangdong
Country
CHINAAddress
Rm8c Bldg Yong Fu Guo Qi Building Shang, , 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).
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2012 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | New Orleans District Office (NOL-DO) | |
| 12/15/2011 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 12/14/2011 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 12/14/2011 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 12/14/2011 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 12/14/2011 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Quadrep Electronies(C)Ltd.'s FDA import refusal history?
Quadrep Electronies(C)Ltd. (FEI: 3008362718) has 9 FDA import refusal record(s) in our database, spanning from 12/14/2011 to 1/6/2012.
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. Quadrep Electronies(C)Ltd.'s FEI number is 3008362718.
What types of violations has Quadrep Electronies(C)Ltd. received?
Quadrep Electronies(C)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 Quadrep Electronies(C)Ltd. come from?
All FDA import refusal data for Quadrep Electronies(C)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.