Best Farm Llc
⚠️ Moderate Risk
FEI: 3012010402 • Moscow, Kirovskaya obl • RUSSIA
FEI Number
3012010402
Location
Moscow, Kirovskaya obl
Country
RUSSIAAddress
Russian Federationbolshoy Karetny Per, , Moscow, Kirovskaya obl, 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).
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.
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.
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).
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 5/24/2017 | 60CCL53XYLOMETAZOLINE HCL (ADRENERGIC) | Division of Northeast Imports (DNEI) | |
| 1/12/2017 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/5/2017 | 62FNL20IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Northeast Imports (DNEI) | |
| 1/5/2017 | 62FBJ20IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Northeast Imports (DNEI) | |
| 1/5/2017 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 1/5/2017 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 2/11/2016 | 33AGT05CANDY BARS OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)(WITHOUT | 324NO ENGLISH | New York District Office (NYK-DO) |
| 2/11/2016 | 33AGT05CANDY BARS OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)(WITHOUT | 324NO ENGLISH | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Best Farm Llc's FDA import refusal history?
Best Farm Llc (FEI: 3012010402) has 8 FDA import refusal record(s) in our database, spanning from 2/11/2016 to 5/24/2017.
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. Best Farm Llc's FEI number is 3012010402.
What types of violations has Best Farm Llc received?
Best Farm Llc has been cited for 8 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 Best Farm Llc come from?
All FDA import refusal data for Best Farm Llc 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.