Bristol Myers Squibb
⚠️ Moderate Risk
FEI: 1000527006 • Princeton, NJ • UNITED STATES
FEI Number
1000527006
Location
Princeton, NJ
Country
UNITED STATESAddress
Route 206 & Province Line Road, , Princeton, 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
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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/10/2008 | 66NCA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/10/2008 | 66NCA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 3/1/2006 | 61FDB61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/23/2005 | 56BIL55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bristol Myers Squibb's FDA import refusal history?
Bristol Myers Squibb (FEI: 1000527006) has 4 FDA import refusal record(s) in our database, spanning from 5/23/2005 to 10/10/2008.
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 1000527006.
What types of violations has Bristol Myers Squibb received?
Bristol Myers Squibb has been cited for 3 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.