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Bristol-Myers Squibb Manufacturing Company

⚠️ Moderate Risk

FEI: 2627673 • Mayaguez, PR • UNITED STATES

FEI

FEI Number

2627673

📍

Location

Mayaguez, PR

🇺🇸
🏢

Address

Carr # 114 Km 3.2, , Mayaguez, PR, United States

Moderate Risk

FDA Import Risk Assessment

42.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
6/2/2023
Latest Refusal
3/26/2002
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
33.6×20%
Frequency
0.9×10%
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

1791×

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.

751×

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).

Refusal History

DateProductViolationsDivision
6/2/2023
61LCY44APIXABAN (ANTI-COAGULANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/26/2002
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Bristol-Myers Squibb Manufacturing Company's FDA import refusal history?

Bristol-Myers Squibb Manufacturing Company (FEI: 2627673) has 2 FDA import refusal record(s) in our database, spanning from 3/26/2002 to 6/2/2023.

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 Manufacturing Company's FEI number is 2627673.

What types of violations has Bristol-Myers Squibb Manufacturing Company received?

Bristol-Myers Squibb Manufacturing Company has been cited for 2 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 Manufacturing Company come from?

All FDA import refusal data for Bristol-Myers Squibb Manufacturing 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.