Bristol Myers Squibb P.G.
⚠️ Moderate Risk
FEI: 1000527885 • Saint-Laurent, QC • CANADA
FEI Number
1000527885
Location
Saint-Laurent, QC
Country
CANADAAddress
2365 Cote De Liesse, , Saint-Laurent, QC, Canada
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2012 | 61NCB60TRAZODONE HCL (ANTI-DEPRESSANT) | Florida District Office (FLA-DO) | |
| 11/30/2012 | 66NCB06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | Florida District Office (FLA-DO) | |
| 10/19/2009 | 64UDB01CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/30/2009 | 61LDP38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/14/2009 | 64UCA03CARBIDOPA (INHIBITOR (DECARBOXYLASE)) | Detroit District Office (DET-DO) | |
| 11/6/2006 | 62VCH53REYATAZ | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/6/2006 | 62VCH23DIDANOSINE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCP37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCN37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 62OCN37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/18/2004 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/19/2003 | 62IQA39MITOTANE (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bristol Myers Squibb P.G.'s FDA import refusal history?
Bristol Myers Squibb P.G. (FEI: 1000527885) has 13 FDA import refusal record(s) in our database, spanning from 11/19/2003 to 11/30/2012.
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 P.G.'s FEI number is 1000527885.
What types of violations has Bristol Myers Squibb P.G. received?
Bristol Myers Squibb P.G. 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 P.G. come from?
All FDA import refusal data for Bristol Myers Squibb P.G. 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.