Assol Ooo
⚠️ Moderate Risk
FEI: 3010461821 • Sankt-peterburg, Sankt-peterburg • RUSSIA
FEI Number
3010461821
Location
Sankt-peterburg, Sankt-peterburg
Country
RUSSIAAddress
Reki Mojki Nab 122, , Sankt-peterburg, Sankt-peterburg, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2015 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 64XAY06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 64XAY06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 63HAY99CATHARTIC N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 63HCL99CATHARTIC N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 2/24/2015 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Assol Ooo's FDA import refusal history?
Assol Ooo (FEI: 3010461821) has 8 FDA import refusal record(s) in our database, spanning from 2/24/2015 to 2/24/2015.
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 Ooo's FEI number is 3010461821.
What types of violations has Assol Ooo received?
Assol Ooo has been cited for 1 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 Ooo come from?
All FDA import refusal data for Assol Ooo 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.