Josphine Bwalya
⚠️ Moderate Risk
FEI: 3008016549 • Lusaka, Lusaka • ZAMBIA
FEI Number
3008016549
Location
Lusaka, Lusaka
Country
ZAMBIAAddress
P.O. Box 30499lusakazambia, , Lusaka, Lusaka, Zambia
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 |
|---|---|---|---|
| 12/29/2009 | 62LIY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/29/2009 | 60WIY16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/29/2009 | 61FIY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/29/2009 | 61GIY57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Josphine Bwalya's FDA import refusal history?
Josphine Bwalya (FEI: 3008016549) has 4 FDA import refusal record(s) in our database, spanning from 12/29/2009 to 12/29/2009.
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. Josphine Bwalya's FEI number is 3008016549.
What types of violations has Josphine Bwalya received?
Josphine Bwalya 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 Josphine Bwalya come from?
All FDA import refusal data for Josphine Bwalya 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.