FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV
⚠️ Moderate Risk
FEI: 3024143674 • Kharkiv, Kharkivska Oblast • UKRAINE
FEI Number
3024143674
Location
Kharkiv, Kharkivska Oblast
Country
UKRAINEAddress
Bud. 22 Vul. Shevchenka, , Kharkiv, Kharkivska Oblast, Ukraine
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)
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).
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).
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
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)).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 54BCB11POTASSIUM (MINERAL) | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 54KCL03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/9/2023 | 54FBL16LICORICE (HERBAL & BOTANICALS, NOT TEAS) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV's FDA import refusal history?
FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV (FEI: 3024143674) has 8 FDA import refusal record(s) in our database, spanning from 3/9/2023 to 9/7/2023.
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. FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV's FEI number is 3024143674.
What types of violations has FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV received?
FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV has been cited for 7 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 FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV come from?
All FDA import refusal data for FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV 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.