TEVA UK Limited
⚠️ High Risk
FEI: 3005673040 • Eastbourne • UNITED KINGDOM
FEI Number
3005673040
Location
Eastbourne
Country
UNITED KINGDOMAddress
Unknown, , Eastbourne, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2018 | 61WCH45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/1/2018 | 62OCY27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 61JDA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 62KDE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 62JDA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 62ODA18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2018 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/4/2016 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/30/2012 | 62TCB07PANTOPRAZOLE SODIUM | Florida District Office (FLA-DO) | |
| 10/12/2012 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2012 | 61JDB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2012 | 62IDP77ETOPOSIDE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 2/21/2012 | 62ZDP01CARBOPLATIN (ANTI-NEOPLASTIC - PART II) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 8/20/2009 | 62CAA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is TEVA UK Limited's FDA import refusal history?
TEVA UK Limited (FEI: 3005673040) has 17 FDA import refusal record(s) in our database, spanning from 8/20/2009 to 5/15/2018.
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. TEVA UK Limited's FEI number is 3005673040.
What types of violations has TEVA UK Limited received?
TEVA UK Limited has been cited for 2 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 TEVA UK Limited come from?
All FDA import refusal data for TEVA UK Limited 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.