ASSOL

⚠️ Moderate Risk

FEI: 3012758196 • Saint Petersburg • RUSSIA

FEI

FEI Number

3012758196

📍

Location

Saint Petersburg

🇷🇺

Country

RUSSIA

🏢

Address

Building 1, Nastavnikov Prospect 41, Saint Petersburg, , Russia

Moderate Risk

FDA Import Risk Assessment

36.5

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

3/28/2017

Latest Refusal

10/28/2016

Earliest Refusal

Score Breakdown

Violation Severity

36.4×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

4737×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

3414×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
3/28/2017	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	473LABELING	Division of Northern Border Imports (DNBI)
3/28/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	473LABELING	Division of Northern Border Imports (DNBI)
3/28/2017	53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.	473LABELING	Division of Northern Border Imports (DNBI)
3/28/2017	54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	473LABELING	Division of Northern Border Imports (DNBI)
3/28/2017	54FYT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	473LABELING	Division of Northern Border Imports (DNBI)
3/28/2017	54EYT99HERBALS & BOTANICAL TEAS, N.E.C.	473LABELING	Division of Northern Border Imports (DNBI)
3/28/2017	54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	473LABELING	Division of Northern Border Imports (DNBI)
10/28/2016	89LYGMASSAGER, THERAPEUTIC, MANUAL	341REGISTERED	Division of Northeast Imports (DNEI)
10/28/2016	80FQMBANDAGE, ELASTIC	341REGISTERED	Division of Northeast Imports (DNEI)
10/28/2016	89OMWADHESIVE BACKED THERMAL SKIN PATCHES	341REGISTERED	Division of Northeast Imports (DNEI)
10/28/2016	89OMWADHESIVE BACKED THERMAL SKIN PATCHES	341REGISTERED	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is ASSOL's FDA import refusal history?

ASSOL (FEI: 3012758196) has 11 FDA import refusal record(s) in our database, spanning from 10/28/2016 to 3/28/2017.

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. ASSOL's FEI number is 3012758196.

What types of violations has ASSOL received?

ASSOL 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 ASSOL come from?

All FDA import refusal data for ASSOL 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.