Pharmaceutical Company Zdorv'E Ltd
⚠️ Moderate Risk
FEI: 3008616935 • Kharkov • UKRAINE
FEI Number
3008616935
Location
Kharkov
Country
UKRAINEAddress
22 Shevchenko Street, , Kharkov, , 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. 201.15(c)(1).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/3/2011 | 63EDA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pharmaceutical Company Zdorv'E Ltd's FDA import refusal history?
Pharmaceutical Company Zdorv'E Ltd (FEI: 3008616935) has 4 FDA import refusal record(s) in our database, spanning from 6/3/2011 to 6/28/2011.
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. Pharmaceutical Company Zdorv'E Ltd's FEI number is 3008616935.
What types of violations has Pharmaceutical Company Zdorv'E Ltd received?
Pharmaceutical Company Zdorv'E Ltd has been cited for 4 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 Pharmaceutical Company Zdorv'E Ltd come from?
All FDA import refusal data for Pharmaceutical Company Zdorv'E Ltd 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.