Farmakom Ltd
⚠️ Moderate Risk
FEI: 3008616929 • Kharkiv, Kharkivska • UKRAINE
FEI Number
3008616929
Location
Kharkiv, Kharkivska
Country
UKRAINEAddress
17 Yuriivska Street, , Kharkiv, Kharkivska, Ukraine
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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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
Frequently Asked Questions
What is Farmakom Ltd's FDA import refusal history?
Farmakom Ltd (FEI: 3008616929) has 1 FDA import refusal record(s) in our database, spanning from 8/27/2020 to 8/27/2020.
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. Farmakom Ltd's FEI number is 3008616929.
What types of violations has Farmakom Ltd received?
Farmakom Ltd 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 Farmakom Ltd come from?
All FDA import refusal data for Farmakom Ltd 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.