KYIVSKY VITAMINNY ZAVOD, AT
⚠️ High Risk
FEI: 3025915064 • Kopylivska Kyiv • UKRAINE
FEI Number
3025915064
Location
Kopylivska Kyiv
Country
UKRAINEAddress
Bud. 38 Vul., , Kopylivska Kyiv, , 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
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).
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. 801.15(c)(1)
UNSAFE COL
The article appears to be, or to bear or contain a color additive which 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2023 | 64HBA02GUAIFENESIN (EXPECTORANT) | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 64HBA02GUAIFENESIN (EXPECTORANT) | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 63HAA23SENNOSIDES A AND B (CATHARTIC) | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 66VAM99MISCELLANEOUS 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) | |
| 9/7/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 9/7/2023 | 54FCB20MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) | 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) |
Frequently Asked Questions
What is KYIVSKY VITAMINNY ZAVOD, AT's FDA import refusal history?
KYIVSKY VITAMINNY ZAVOD, AT (FEI: 3025915064) has 15 FDA import refusal record(s) in our database, spanning from 9/7/2023 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. KYIVSKY VITAMINNY ZAVOD, AT's FEI number is 3025915064.
What types of violations has KYIVSKY VITAMINNY ZAVOD, AT received?
KYIVSKY VITAMINNY ZAVOD, AT has been cited for 6 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 KYIVSKY VITAMINNY ZAVOD, AT come from?
All FDA import refusal data for KYIVSKY VITAMINNY ZAVOD, AT 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.