MEVISA COMPONENTES SA DE CV
⚠️ High Risk
FEI: 3030149487 • San Pedro Garza Garcia, Nuevo Leon • MEXICO
FEI Number
3030149487
Location
San Pedro Garza Garcia, Nuevo Leon
Country
MEXICOAddress
Ampliacion Villas De San Agustin, San Pedro Garza Garcia, Avenida Lazaro Cardenas 2321 Int Po3, San Pedro Garza Garcia, Nuevo Leon, Mexico
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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2024 | 57HH99BACTERIAL VACCINES/ANTIGENS, N.E.C. | 71NO LICENSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEVISA COMPONENTES SA DE CV's FDA import refusal history?
MEVISA COMPONENTES SA DE CV (FEI: 3030149487) has 1 FDA import refusal record(s) in our database, spanning from 1/3/2024 to 1/3/2024.
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. MEVISA COMPONENTES SA DE CV's FEI number is 3030149487.
What types of violations has MEVISA COMPONENTES SA DE CV received?
MEVISA COMPONENTES SA DE CV has been cited for 1 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 MEVISA COMPONENTES SA DE CV come from?
All FDA import refusal data for MEVISA COMPONENTES SA DE CV 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.