Maria Elizabeth Arbaiza
⚠️ High Risk
FEI: 3009858449 • Mejicanos, San Salvador • EL SALVADOR
FEI Number
3009858449
Location
Mejicanos, San Salvador
Country
EL SALVADORAddress
Condominio Belmary Edificio 4d, , Mejicanos, San Salvador, El Salvador
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
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 |
|---|---|---|---|
| 12/31/2012 | 64HDA07TERPIN HYDRATE (EXPECTORANT) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 64HDA07TERPIN HYDRATE (EXPECTORANT) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 56ADA99PENICILLIN NATURAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60ICA12SODIUM CITRATE (ALKALIZER) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 61XDA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 61XDA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 61XDA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 12/31/2012 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Maria Elizabeth Arbaiza's FDA import refusal history?
Maria Elizabeth Arbaiza (FEI: 3009858449) has 26 FDA import refusal record(s) in our database, spanning from 12/31/2012 to 12/31/2012.
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. Maria Elizabeth Arbaiza's FEI number is 3009858449.
What types of violations has Maria Elizabeth Arbaiza received?
Maria Elizabeth Arbaiza 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 Maria Elizabeth Arbaiza come from?
All FDA import refusal data for Maria Elizabeth Arbaiza 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.