OOO ETALON
⚠️ Moderate Risk
FEI: 3008930069 • Moscow, Moskovskaya oblast • RUSSIA
FEI Number
3008930069
Location
Moscow, Moskovskaya oblast
Country
RUSSIAAddress
Bolshay Ordinak 54, , Moscow, Moskovskaya oblast, 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
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.
CYCLAMATE
The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2012 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 9/19/2011 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 324NO ENGLISH | New York District Office (NYK-DO) |
| 9/19/2011 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | New York District Office (NYK-DO) | |
| 9/19/2011 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | New York District Office (NYK-DO) | |
| 9/19/2011 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | New York District Office (NYK-DO) | |
| 9/19/2011 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is OOO ETALON's FDA import refusal history?
OOO ETALON (FEI: 3008930069) has 6 FDA import refusal record(s) in our database, spanning from 9/19/2011 to 3/2/2012.
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. OOO ETALON's FEI number is 3008930069.
What types of violations has OOO ETALON received?
OOO ETALON has been cited for 4 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 OOO ETALON come from?
All FDA import refusal data for OOO ETALON 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.