Aventis Pharma Limited (South Africa)
⚠️ Moderate Risk
FEI: 3004497311 • Silverton, Northern Region • SOUTH AFRICA
FEI Number
3004497311
Location
Silverton, Northern Region
Country
SOUTH AFRICAAddress
315 Waltloo Road, , Silverton, Northern Region, South Africa
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 |
|---|---|---|---|
| 8/11/2015 | 61JDY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/5/2007 | 64MDY01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 60LDE21DIPYRONE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aventis Pharma Limited (South Africa)'s FDA import refusal history?
Aventis Pharma Limited (South Africa) (FEI: 3004497311) has 3 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 8/11/2015.
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. Aventis Pharma Limited (South Africa)'s FEI number is 3004497311.
What types of violations has Aventis Pharma Limited (South Africa) received?
Aventis Pharma Limited (South Africa) 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 Aventis Pharma Limited (South Africa) come from?
All FDA import refusal data for Aventis Pharma Limited (South Africa) 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.