Direct Medicine Pharmacy
⚠️ Moderate Risk
FEI: 3004424089 • Roodeport • SOUTH AFRICA
FEI Number
3004424089
Location
Roodeport
Country
SOUTH AFRICAAddress
146 Durban Deep Road, , Roodeport, , 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).
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 |
|---|---|---|---|
| 4/1/2004 | 65RDA01CALCIUM CHLORIDE (REPLENISHER) | New York District Office (NYK-DO) | |
| 4/1/2004 | 64GDA16CONJUGATED ESTROGENS (ESTROGEN) | New York District Office (NYK-DO) | |
| 4/1/2004 | 65RDA14POTASSIUM CHLORIDE (REPLENISHER) | New York District Office (NYK-DO) | |
| 4/1/2004 | 63ADA06RALOXIFENE HCL (BONE CALCIUM REGULATOR) | New York District Office (NYK-DO) | |
| 4/1/2004 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | New York District Office (NYK-DO) | |
| 4/1/2004 | 61JDA01BELOXAMIDE (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 4/1/2004 | 66MDA09BUSPIRONE HCL (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 4/1/2004 | 61NDA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 4/1/2004 | 60LDA83CELECOXIB (ANALGESIC) | New York District Office (NYK-DO) | |
| 4/1/2004 | 62ODA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) | |
| 4/1/2004 | 60XDA23TIMOLOL MALEATE (ANTI-ADRENERGIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Direct Medicine Pharmacy's FDA import refusal history?
Direct Medicine Pharmacy (FEI: 3004424089) has 11 FDA import refusal record(s) in our database, spanning from 4/1/2004 to 4/1/2004.
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. Direct Medicine Pharmacy's FEI number is 3004424089.
What types of violations has Direct Medicine Pharmacy received?
Direct Medicine Pharmacy has been cited for 2 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 Direct Medicine Pharmacy come from?
All FDA import refusal data for Direct Medicine 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.