Bristol Myers Squibb
⚠️ Moderate Risk
FEI: 3010946484 • Pennington, NJ • UNITED STATES
FEI Number
3010946484
Location
Pennington, NJ
Country
UNITED STATESAddress
PO Box 5400, , Pennington, NJ, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/25/2016 | 62VDB12RIBAVIRIN (ANTI-VIRAL) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/5/2012 | 61LCA13WARFARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2011 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2009 | 62ODA44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2009 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/25/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/21/2008 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/11/2007 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/2/2006 | 61LCB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 64LCL60TRIAMCINOLONE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/8/2005 | 61PCA26METFORMIN (ANTI-DIABETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bristol Myers Squibb's FDA import refusal history?
Bristol Myers Squibb (FEI: 3010946484) has 11 FDA import refusal record(s) in our database, spanning from 9/8/2005 to 5/25/2016.
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 3010946484.
What types of violations has Bristol Myers Squibb received?
Bristol Myers Squibb 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 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.