ZENTIVA PHARMA UK LTD
⚠️ High Risk
FEI: 3016688950 • London • UNITED KINGDOM
FEI Number
3016688950
Location
London
Country
UNITED KINGDOMAddress
12 New Fetter Ln, , London, , United Kingdom
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2025 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2022 | 56YDA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZENTIVA PHARMA UK LTD's FDA import refusal history?
ZENTIVA PHARMA UK LTD (FEI: 3016688950) has 4 FDA import refusal record(s) in our database, spanning from 10/5/2020 to 1/14/2025.
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. ZENTIVA PHARMA UK LTD's FEI number is 3016688950.
What types of violations has ZENTIVA PHARMA UK LTD received?
ZENTIVA PHARMA UK LTD has been cited for 1 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 ZENTIVA PHARMA UK LTD come from?
All FDA import refusal data for ZENTIVA PHARMA UK 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.