M. REPRESENTACIONES SA DE CV
⚠️ Moderate Risk
FEI: 3014431521 • San Salvador • EL SALVADOR
FEI Number
3014431521
Location
San Salvador
Country
EL SALVADORAddress
Calle Alirio Carnejo No, , San Salvador, , El Salvador
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/23/2018 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/23/2018 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/23/2018 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is M. REPRESENTACIONES SA DE CV's FDA import refusal history?
M. REPRESENTACIONES SA DE CV (FEI: 3014431521) has 3 FDA import refusal record(s) in our database, spanning from 5/23/2018 to 5/23/2018.
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. M. REPRESENTACIONES SA DE CV's FEI number is 3014431521.
What types of violations has M. REPRESENTACIONES SA DE CV received?
M. REPRESENTACIONES SA DE CV 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 M. REPRESENTACIONES SA DE CV come from?
All FDA import refusal data for M. REPRESENTACIONES 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.