Penka Dimitrova Stefanova
⚠️ Moderate Risk
FEI: 3006338504 • Sofia, Sofia • BULGARIA
FEI Number
3006338504
Location
Sofia, Sofia
Country
BULGARIAAddress
Bul.Tsar Osvoboditel 8, , Sofia, Sofia, Bulgaria
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 |
|---|---|---|---|
| 8/27/2007 | 62FCQ08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2007 | 61WCJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2007 | 61GDA40SPIRAMYCIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2007 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Penka Dimitrova Stefanova's FDA import refusal history?
Penka Dimitrova Stefanova (FEI: 3006338504) has 4 FDA import refusal record(s) in our database, spanning from 8/27/2007 to 8/27/2007.
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. Penka Dimitrova Stefanova's FEI number is 3006338504.
What types of violations has Penka Dimitrova Stefanova received?
Penka Dimitrova Stefanova 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 Penka Dimitrova Stefanova come from?
All FDA import refusal data for Penka Dimitrova Stefanova 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.