Bristol Myers/Squibb Co
⚠️ Moderate Risk
FEI: 2418982 • New York, NY • UNITED STATES
FEI Number
2418982
Location
New York, NY
Country
UNITED STATESAddress
345 Park Ave, , New York, NY, 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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 |
|---|---|---|---|
| 11/21/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2010 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/3/2008 | 61PCN26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/3/2008 | 62OBP34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/5/2006 | 55PY97METHYL SALICYLATE (PHARMACEUTIC NECESSITY - FLAVOR) | San Francisco District Office (SAN-DO) | |
| 10/19/2004 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
| 9/12/2003 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bristol Myers/Squibb Co's FDA import refusal history?
Bristol Myers/Squibb Co (FEI: 2418982) has 7 FDA import refusal record(s) in our database, spanning from 9/12/2003 to 11/21/2016.
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 Co's FEI number is 2418982.
What types of violations has Bristol Myers/Squibb Co received?
Bristol Myers/Squibb Co 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 Co come from?
All FDA import refusal data for Bristol Myers/Squibb Co 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.