Bristol-Myers Squibb
⚠️ High Risk
FEI: 3002433621 • Singapore • SINGAPORE
FEI Number
3002433621
Location
Singapore
Country
SINGAPOREAddress
6668 East Coast Road, , Singapore, , Singapore
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 |
|---|---|---|---|
| 5/8/2006 | 60SCP99ANTACID, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 63FCP99CARDIOTONIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 62OCP10TERAZOSIN HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 61NCP69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 61TCP12METOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 66MCP83HYDROXYZINE HCL (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 66SCP27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 61JCP13PRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 62GCP99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 61LCP38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 63BCP25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 63ACP02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 62OCP15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 61QCY99ANTI-DIURETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 61PCA28TOLAZAMIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bristol-Myers Squibb's FDA import refusal history?
Bristol-Myers Squibb (FEI: 3002433621) has 15 FDA import refusal record(s) in our database, spanning from 2/24/2004 to 5/8/2006.
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-Myers Squibb's FEI number is 3002433621.
What types of violations has Bristol-Myers Squibb received?
Bristol-Myers Squibb 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-Myers Squibb come from?
All FDA import refusal data for Bristol-Myers Squibb 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.