NIKITIN YURIY
⚠️ Moderate Risk
FEI: 3013463085 • Kiev • UKRAINE
FEI Number
3013463085
Location
Kiev
Country
UKRAINEAddress
Fastiv City, Sovetska 2, , Kiev, , 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
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
VET LEGEND
The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2017 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | Division of West Coast Imports (DWCI) | |
| 6/19/2017 | 68KYY99OTHER ANIMAL, N.E.C. WOUND DRESSING | Division of West Coast Imports (DWCI) | |
| 6/6/2017 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/6/2017 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/6/2017 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/6/2017 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NIKITIN YURIY's FDA import refusal history?
NIKITIN YURIY (FEI: 3013463085) has 6 FDA import refusal record(s) in our database, spanning from 6/6/2017 to 6/19/2017.
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. NIKITIN YURIY's FEI number is 3013463085.
What types of violations has NIKITIN YURIY received?
NIKITIN YURIY 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 NIKITIN YURIY come from?
All FDA import refusal data for NIKITIN YURIY 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.