ARLEX DE MEXICO SA DE CV
⚠️ Moderate Risk
FEI: 3012410990 • Mexico Df • MEXICO
FEI Number
3012410990
Location
Mexico Df
Country
MEXICOAddress
Puerto Acapulco # 35, , Mexico Df, , 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
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 |
|---|---|---|---|
| 11/30/2021 | 62VCJ18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 60QDY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 62KDY08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 60QDY07LIDOCAINE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 62KDY08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/28/2016 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ARLEX DE MEXICO SA DE CV's FDA import refusal history?
ARLEX DE MEXICO SA DE CV (FEI: 3012410990) has 6 FDA import refusal record(s) in our database, spanning from 11/28/2016 to 11/30/2021.
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. ARLEX DE MEXICO SA DE CV's FEI number is 3012410990.
What types of violations has ARLEX DE MEXICO SA DE CV received?
ARLEX DE MEXICO 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 ARLEX DE MEXICO SA DE CV come from?
All FDA import refusal data for ARLEX DE MEXICO 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.