FARMAKOR PRODAKSN LLC
⚠️ High Risk
FEI: 3027126123 • St Petersburg • RUSSIA
FEI Number
3027126123
Location
St Petersburg
Country
RUSSIAAddress
Repischeva St 14 Buildi, , St Petersburg, , Russia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2025 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 218LIST INGRE | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 63XDE92THYROTROPIN ALFA INJECTION (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 63BDE20SULFONTEROL HCL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FARMAKOR PRODAKSN LLC's FDA import refusal history?
FARMAKOR PRODAKSN LLC (FEI: 3027126123) has 7 FDA import refusal record(s) in our database, spanning from 12/8/2023 to 2/21/2025.
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. FARMAKOR PRODAKSN LLC's FEI number is 3027126123.
What types of violations has FARMAKOR PRODAKSN LLC received?
FARMAKOR PRODAKSN LLC 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 FARMAKOR PRODAKSN LLC come from?
All FDA import refusal data for FARMAKOR PRODAKSN LLC 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.