ASPEN PORT ELIZABETH PTY LTD
⚠️ High Risk
FEI: 3013522351 • Port Elizabeth • SOUTH AFRICA
FEI Number
3013522351
Location
Port Elizabeth
Country
SOUTH AFRICAAddress
Cmr Fairclough Rd, , Port Elizabeth, , South Africa
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 |
|---|---|---|---|
| 5/22/2024 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ASPEN PORT ELIZABETH PTY LTD's FDA import refusal history?
ASPEN PORT ELIZABETH PTY LTD (FEI: 3013522351) has 1 FDA import refusal record(s) in our database, spanning from 5/22/2024 to 5/22/2024.
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. ASPEN PORT ELIZABETH PTY LTD's FEI number is 3013522351.
What types of violations has ASPEN PORT ELIZABETH PTY LTD received?
ASPEN PORT ELIZABETH PTY LTD 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 ASPEN PORT ELIZABETH PTY LTD come from?
All FDA import refusal data for ASPEN PORT ELIZABETH PTY LTD 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.