Bristol-Myers Squibb
⚠️ Moderate Risk
FEI: 3008480555 • Rueil Malmaison, Hauts de Seine • FRANCE
FEI Number
3008480555
Location
Rueil Malmaison, Hauts de Seine
Country
FRANCEAddress
3 rue Joseph Monier, , Rueil Malmaison, Hauts de Seine, France
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2012 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/9/2011 | 60LCB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/2/2010 | 61XBA21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 7/20/2005 | 62OCY37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/29/2005 | 61XAA39PHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bristol-Myers Squibb's FDA import refusal history?
Bristol-Myers Squibb (FEI: 3008480555) has 6 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 6/11/2012.
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's FEI number is 3008480555.
What types of violations has Bristol-Myers Squibb received?
Bristol-Myers Squibb has been cited for 4 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.