Mrs Kutaykh
⚠️ Moderate Risk
FEI: 3005580984 • Abakan, Khakasiya Resp • RUSSIA
FEI Number
3005580984
Location
Abakan, Khakasiya Resp
Country
RUSSIAAddress
ul. Torosova 18, Apt. 23, , Abakan, Khakasiya Resp, Russia
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 12/11/2006 | 34FFT02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 218LIST INGRE | Cincinnati District Office (CIN-DO) |
| 12/11/2006 | 54FBL40BUCKTHORN (HERBAL & BOTANICALS, NOT TEAS) | 218LIST INGRE | Cincinnati District Office (CIN-DO) |
| 12/11/2006 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/11/2006 | 62GAL99ANTI-INFLAMMATORY N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/11/2006 | 62GAQ99ANTI-INFLAMMATORY N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 12/11/2006 | 62FAL08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mrs Kutaykh's FDA import refusal history?
Mrs Kutaykh (FEI: 3005580984) has 6 FDA import refusal record(s) in our database, spanning from 12/11/2006 to 12/11/2006.
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. Mrs Kutaykh's FEI number is 3005580984.
What types of violations has Mrs Kutaykh received?
Mrs Kutaykh 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 Mrs Kutaykh come from?
All FDA import refusal data for Mrs Kutaykh 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.