Jukskei Park Pharmacy
⚠️ Moderate Risk
FEI: 3005907807 • Randburg • SOUTH AFRICA
FEI Number
3005907807
Location
Randburg
Country
SOUTH AFRICAAddress
J/Park Shopping Centre, , Randburg, , 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 |
|---|---|---|---|
| 10/3/2006 | 61QDC05TOLTERODINE TARTRATE (ANTI-DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2006 | 66QCC10PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/3/2006 | 63BDC25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Jukskei Park Pharmacy's FDA import refusal history?
Jukskei Park Pharmacy (FEI: 3005907807) has 3 FDA import refusal record(s) in our database, spanning from 10/3/2006 to 10/3/2006.
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. Jukskei Park Pharmacy's FEI number is 3005907807.
What types of violations has Jukskei Park Pharmacy received?
Jukskei Park Pharmacy 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 Jukskei Park Pharmacy come from?
All FDA import refusal data for Jukskei Park Pharmacy 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.