Dr Jp Van Der Merwe
⚠️ Moderate Risk
FEI: 3005488818 • Tygerberg • SOUTH AFRICA
FEI Number
3005488818
Location
Tygerberg
Country
SOUTH AFRICAAddress
Posbus 190558 Po Box, , Tygerberg, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/13/2006 | 64MCP99GONAD-STIMULATING PRINCIPLE N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/3/2006 | 64MCP07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE) | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/3/2006 | 64MCP05MENOTROPINS (GONAD-STIMULATING PRINCIPLE) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dr Jp Van Der Merwe's FDA import refusal history?
Dr Jp Van Der Merwe (FEI: 3005488818) has 3 FDA import refusal record(s) in our database, spanning from 2/3/2006 to 2/13/2006.
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. Dr Jp Van Der Merwe's FEI number is 3005488818.
What types of violations has Dr Jp Van Der Merwe received?
Dr Jp Van Der Merwe 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 Dr Jp Van Der Merwe come from?
All FDA import refusal data for Dr Jp Van Der Merwe 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.