Alice Molefe
⚠️ Moderate Risk
FEI: 3004622833 • Gaborone • BOTSWANA
FEI Number
3004622833
Location
Gaborone
Country
BOTSWANAAddress
P.O.Box 10125, , Gaborone, , Botswana
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2004 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New York District Office (NYK-DO) | |
| 8/18/2004 | 62SCO02ADAPALENE (ANTI-SEBORRHEIC) | New York District Office (NYK-DO) | |
| 8/18/2004 | 63ADE99BONE CALCIUM REGULATOR N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alice Molefe's FDA import refusal history?
Alice Molefe (FEI: 3004622833) has 3 FDA import refusal record(s) in our database, spanning from 8/18/2004 to 8/18/2004.
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. Alice Molefe's FEI number is 3004622833.
What types of violations has Alice Molefe received?
Alice Molefe has been cited for 3 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 Alice Molefe come from?
All FDA import refusal data for Alice Molefe 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.