BRISTOL LABORTORIES LTD
⚠️ Moderate Risk
FEI: 3012341899 • Berkhamsted, Hertfordshire • UNITED KINGDOM
FEI Number
3012341899
Location
Berkhamsted, Hertfordshire
Country
UNITED KINGDOMAddress
Unit 3, Northbridge Road, Berkhamsted, Hertfordshire, United Kingdom
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
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 |
|---|---|---|---|
| 10/28/2021 | 60XCY17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 60XDA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 60LBA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2020 | 60XCY17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2017 | 61TDE31DOMPERIDONE | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/25/2012 | 62OCA20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 64BAA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BRISTOL LABORTORIES LTD's FDA import refusal history?
BRISTOL LABORTORIES LTD (FEI: 3012341899) has 7 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 10/28/2021.
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 LABORTORIES LTD's FEI number is 3012341899.
What types of violations has BRISTOL LABORTORIES LTD received?
BRISTOL LABORTORIES 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 LABORTORIES LTD come from?
All FDA import refusal data for BRISTOL LABORTORIES 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.