Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
⚠️ Moderate Risk
FEI: 2650089 • Manati, PR • UNITED STATES
FEI Number
2650089
Location
Manati, PR
Country
UNITED STATESAddress
Rd # 686, Km # 2.3, Sector Cotto Norte, Bo. Tierras Nuevas, Manati, PR, 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).
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).
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 |
|---|---|---|---|
| 1/12/2023 | 61LCE44APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2020 | 61LDA99ANTI-COAGULANT, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 66WCP01ABATACEPT (IMMUNOMODULATOR) | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 66WCP01ABATACEPT (IMMUNOMODULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2018 | 66WCP01ABATACEPT (IMMUNOMODULATOR) | Division of Southeast Imports (DSEI) | |
| 2/27/2018 | 66WCP01ABATACEPT (IMMUNOMODULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2018 | 66WCP01ABATACEPT (IMMUNOMODULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2017 | 61LCA99ANTI-COAGULANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2016 | 62ZDY13DASATINIB | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company's FDA import refusal history?
Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company (FEI: 2650089) has 9 FDA import refusal record(s) in our database, spanning from 4/20/2016 to 1/12/2023.
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 Holdings Pharma Ltd. Liability Company's FEI number is 2650089.
What types of violations has Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company received?
Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company 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 Holdings Pharma Ltd. Liability Company come from?
All FDA import refusal data for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company 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.