FARMACEUTICOS RAYERE SA
⚠️ High Risk
FEI: 3012403613 • Benito Juarez • MEXICO
FEI Number
3012403613
Location
Benito Juarez
Country
MEXICOAddress
Emiliano Zapata NO 72 C, , Benito Juarez, , 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
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 |
|---|---|---|---|
| 11/28/2023 | 65PCA57CARISOPRODOL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2023 | 61TDY06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2020 | 61WCE45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2019 | 61WCE45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2017 | 64HDA99EXPECTORANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is FARMACEUTICOS RAYERE SA's FDA import refusal history?
FARMACEUTICOS RAYERE SA (FEI: 3012403613) has 6 FDA import refusal record(s) in our database, spanning from 3/24/2017 to 11/28/2023.
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. FARMACEUTICOS RAYERE SA's FEI number is 3012403613.
What types of violations has FARMACEUTICOS RAYERE SA received?
FARMACEUTICOS RAYERE SA 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 FARMACEUTICOS RAYERE SA come from?
All FDA import refusal data for FARMACEUTICOS RAYERE SA 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.