Odessa factory of mineral water "Kuyalnik"
⚠️ Moderate Risk
FEI: 3010011790 • Odesa, Odeska • UKRAINE
FEI Number
3010011790
Location
Odesa, Odeska
Country
UKRAINEAddress
Lymanna vul. 166, , Odesa, Odeska, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2017 | 29WGT02BOTTLED SPRING OR MINERAL WATER | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/25/2013 | 29WHT02BOTTLED SPRING OR MINERAL WATER | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/6/2009 | 29WGT02BOTTLED SPRING OR MINERAL WATER | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Odessa factory of mineral water "Kuyalnik"'s FDA import refusal history?
Odessa factory of mineral water "Kuyalnik" (FEI: 3010011790) has 3 FDA import refusal record(s) in our database, spanning from 1/6/2009 to 7/24/2017.
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. Odessa factory of mineral water "Kuyalnik"'s FEI number is 3010011790.
What types of violations has Odessa factory of mineral water "Kuyalnik" received?
Odessa factory of mineral water "Kuyalnik" 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 Odessa factory of mineral water "Kuyalnik" come from?
All FDA import refusal data for Odessa factory of mineral water "Kuyalnik" 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.