Llc "Unilever Rus"
⚠️ Moderate Risk
FEI: 3009520614 • Moscow, Moscow g • RUSSIA
FEI Number
3009520614
Location
Moscow, Moscow g
Country
RUSSIAAddress
ul. Sergeya Makeeva 13, , Moscow, Moscow g, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 11/9/2020 | 62WBQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 3/20/2019 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/25/2017 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 63RBJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 5/23/2017 | 64XBJ99KERATOLYTIC N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Llc "Unilever Rus"'s FDA import refusal history?
Llc "Unilever Rus" (FEI: 3009520614) has 8 FDA import refusal record(s) in our database, spanning from 5/23/2017 to 11/9/2020.
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. Llc "Unilever Rus"'s FEI number is 3009520614.
What types of violations has Llc "Unilever Rus" received?
Llc "Unilever Rus" has been cited for 5 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 Llc "Unilever Rus" come from?
All FDA import refusal data for Llc "Unilever Rus" 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.