Unknown
⚠️ Moderate Risk
FEI: 3005597802 • Unknown • 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(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.
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).
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/1/2013 | 79GEMGAUZE, ABSORBABLE | Division of Northeast Imports (DNEI) | |
| 2/1/2013 | 80LZBFINGER COT | Division of Northeast Imports (DNEI) | |
| 2/1/2013 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | Division of Northeast Imports (DNEI) | |
| 2/1/2013 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | Division of Northeast Imports (DNEI) | |
| 2/1/2013 | 77BTGBRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) | Division of Northeast Imports (DNEI) | |
| 2/1/2013 | 77BTGBRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Unknown's FDA import refusal history?
Unknown (FEI: 3005597802) has 6 FDA import refusal record(s) in our database, spanning from 2/1/2013 to 2/1/2013.
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. Unknown's FEI number is 3005597802.
What types of violations has Unknown received?
Unknown has been cited for 10 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 Unknown come from?
All FDA import refusal data for Unknown 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.