Jesus Gonzalez Lozada
⚠️ Moderate Risk
FEI: 3011571595 • Reynosa, Tamaulipas • MEXICO
FEI Number
3011571595
Location
Reynosa, Tamaulipas
Country
MEXICOAddress
Calle Ebano No. 138, Col. PRIVADA DEL NORTE, Reynosa, Tamaulipas, Mexico
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).
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 |
|---|---|---|---|
| 7/6/2015 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 90EAMSCREEN, INTENSIFYING, RADIOGRAPHIC | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 73OGLOXYGEN ADMINISTRATION KIT | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 73OGLOXYGEN ADMINISTRATION KIT | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 73OGLOXYGEN ADMINISTRATION KIT | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 74DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC | Southwest Import District Office (SWI-DO) | |
| 7/6/2015 | 90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Jesus Gonzalez Lozada's FDA import refusal history?
Jesus Gonzalez Lozada (FEI: 3011571595) has 10 FDA import refusal record(s) in our database, spanning from 7/6/2015 to 7/6/2015.
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. Jesus Gonzalez Lozada's FEI number is 3011571595.
What types of violations has Jesus Gonzalez Lozada received?
Jesus Gonzalez Lozada 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 Jesus Gonzalez Lozada come from?
All FDA import refusal data for Jesus Gonzalez Lozada 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.