Belmed Preparaty RUE
⚠️ Moderate Risk
FEI: 3010156159 • Minskaya Oblast, BY-MI • BELARUS
FEI Number
3010156159
Location
Minskaya Oblast, BY-MI
Country
BELARUSAddress
30 Fabritsius St, , Minskaya Oblast, BY-MI, Belarus
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 66YBA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 66YBA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 56GCA50NYSTATIN (ANTIFUNGAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Belmed Preparaty RUE's FDA import refusal history?
Belmed Preparaty RUE (FEI: 3010156159) has 4 FDA import refusal record(s) in our database, spanning from 5/24/2017 to 3/9/2023.
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. Belmed Preparaty RUE's FEI number is 3010156159.
What types of violations has Belmed Preparaty RUE received?
Belmed Preparaty RUE 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 Belmed Preparaty RUE come from?
All FDA import refusal data for Belmed Preparaty RUE 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.