Sanofi-Aventis Egypt S.A.E
⚠️ Moderate Risk
FEI: 3009565139 • Al Qahira, Al Qahira • EGYPT
FEI Number
3009565139
Location
Al Qahira, Al Qahira
Country
EGYPTAddress
3 El Massaneh St, , Al Qahira, Al Qahira, Egypt
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 |
|---|---|---|---|
| 4/12/2021 | 60LDA21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/20/2020 | 61HDY43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2020 | 62LDY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 60CDY33HYDROXYAMPHETAMINE HBR (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2019 | 61PDC31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sanofi-Aventis Egypt S.A.E's FDA import refusal history?
Sanofi-Aventis Egypt S.A.E (FEI: 3009565139) has 5 FDA import refusal record(s) in our database, spanning from 6/5/2019 to 4/12/2021.
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. Sanofi-Aventis Egypt S.A.E's FEI number is 3009565139.
What types of violations has Sanofi-Aventis Egypt S.A.E received?
Sanofi-Aventis Egypt S.A.E 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 Sanofi-Aventis Egypt S.A.E come from?
All FDA import refusal data for Sanofi-Aventis Egypt S.A.E 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.