University Of Pretoria
⚠️ Moderate Risk
FEI: 3003835430 • Pretoria, Gauteng • SOUTH AFRICA
FEI Number
3003835430
Location
Pretoria, Gauteng
Country
SOUTH AFRICAAddress
Hillcrest, , Pretoria, Gauteng, 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 |
|---|---|---|---|
| 9/30/2009 | 64BBA37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/30/2009 | 62OBA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/30/2009 | 61JBA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/30/2009 | 61LBA05DICUMAROL (ANTI-COAGULANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/30/2009 | 61MBA40TOPIRAMATE (ANTI-CONVULSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is University Of Pretoria's FDA import refusal history?
University Of Pretoria (FEI: 3003835430) has 5 FDA import refusal record(s) in our database, spanning from 9/30/2009 to 9/30/2009.
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. University Of Pretoria's FEI number is 3003835430.
What types of violations has University Of Pretoria received?
University Of Pretoria 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 University Of Pretoria come from?
All FDA import refusal data for University Of Pretoria 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.