Bristol Myers Squibb
⚠️ Moderate Risk
FEI: 3005583930 • Agen, Lot Et Garonne • FRANCE
FEI Number
3005583930
Location
Agen, Lot Et Garonne
Country
FRANCEAddress
304 avenue du Docteur Jean Bru, , Agen, Lot Et Garonne, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/23/2017 | 60LAL01ACETAMINOPHEN (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 5/22/2017 | 61XAA21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 10/21/2016 | 62GCE99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/26/2014 | 60LBR01ACETAMINOPHEN (ANALGESIC) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 9/22/2008 | 60LAL01ACETAMINOPHEN (ANALGESIC) | Chicago District Office (CHI-DO) | |
| 9/22/2008 | 60LAL01ACETAMINOPHEN (ANALGESIC) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Bristol Myers Squibb's FDA import refusal history?
Bristol Myers Squibb (FEI: 3005583930) has 6 FDA import refusal record(s) in our database, spanning from 9/22/2008 to 5/23/2017.
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 3005583930.
What types of violations has Bristol Myers Squibb received?
Bristol Myers Squibb has been cited for 5 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.