Bristol Laboratories Ltd
⚠️ High Risk
FEI: 3009161444 • Herts • UNITED KINGDOM
FEI Number
3009161444
Location
Herts
Country
UNITED KINGDOMAddress
Berkham Sted, , Herts, , 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 |
|---|---|---|---|
| 7/25/2024 | 62LCY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/29/2021 | 62LDY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2018 | 60XDY17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2016 | 61JCA14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2012 | 60LCB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2012 | 61PDB31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2012 | 62ODB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bristol Laboratories Ltd's FDA import refusal history?
Bristol Laboratories Ltd (FEI: 3009161444) has 7 FDA import refusal record(s) in our database, spanning from 5/23/2012 to 7/25/2024.
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. Bristol Laboratories Ltd's FEI number is 3009161444.
What types of violations has Bristol Laboratories Ltd received?
Bristol Laboratories 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 Bristol Laboratories Ltd come from?
All FDA import refusal data for Bristol Laboratories 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.