Cotronic Technology Limited
⚠️ High Risk
FEI: 3004215929 • Shenzhen, Guangdong • CHINA
FEI Number
3004215929
Location
Shenzhen, Guangdong
Country
CHINAAddress
Floors 4-6, Block 7, West Of Zhoushi Road; Baoan, Shenzhen, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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 |
|---|---|---|---|
| 4/25/2017 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/10/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/2/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 8/22/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 3/21/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/21/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/21/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/14/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/13/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/13/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/13/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 3/13/2014 | 80FLKTHERMOMETER, CLINICAL MERCURY | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/28/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/27/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
| 2/6/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 479DV QUALITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cotronic Technology Limited's FDA import refusal history?
Cotronic Technology Limited (FEI: 3004215929) has 45 FDA import refusal record(s) in our database, spanning from 2/6/2014 to 4/25/2017.
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. Cotronic Technology Limited's FEI number is 3004215929.
What types of violations has Cotronic Technology Limited received?
Cotronic Technology Limited has been cited for 2 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 Cotronic Technology Limited come from?
All FDA import refusal data for Cotronic Technology Limited 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.