Kirka Pharma Corporation D O O
⚠️ Moderate Risk
FEI: 3006094333 • Belgrade • SERBIA
FEI Number
3006094333
Location
Belgrade
Country
SERBIAAddress
Bulevar Mihaila Pupina 10z/Iv, , Belgrade, , Serbia
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2008 | 54ECF99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/23/2008 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/23/2008 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Kirka Pharma Corporation D O O's FDA import refusal history?
Kirka Pharma Corporation D O O (FEI: 3006094333) has 3 FDA import refusal record(s) in our database, spanning from 6/23/2008 to 6/23/2008.
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. Kirka Pharma Corporation D O O's FEI number is 3006094333.
What types of violations has Kirka Pharma Corporation D O O received?
Kirka Pharma Corporation D O O 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 Kirka Pharma Corporation D O O come from?
All FDA import refusal data for Kirka Pharma Corporation D O O 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.