NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV
⚠️ High Risk
FEI: 3024142930 • Kharkiv, Kharkivska Oblast • UKRAINE
FEI Number
3024142930
Location
Kharkiv, Kharkivska Oblast
Country
UKRAINEAddress
Bud. 34 Kv. 60, Vul. Groznenska, , Kharkiv, Kharkivska Oblast, Ukraine
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing 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 | 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) | |
| 3/9/2023 | 64HBL99EXPECTORANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/9/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV's FDA import refusal history?
NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV (FEI: 3024142930) has 10 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. NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV's FEI number is 3024142930.
What types of violations has NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV received?
NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV 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 NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV come from?
All FDA import refusal data for NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, 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.