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BRISTOL MYERS SQUIBB BRASIL SA

⚠️ Moderate Risk

FEI: 3012452568 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

3012452568

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Verbo Divino 1711, , Sao Paulo, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/13/2018
Latest Refusal
12/13/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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
12/13/2018
56EYY99TETRACYCLINE N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BRISTOL MYERS SQUIBB BRASIL SA's FDA import refusal history?

BRISTOL MYERS SQUIBB BRASIL SA (FEI: 3012452568) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2018 to 12/13/2018.

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 BRASIL SA's FEI number is 3012452568.

What types of violations has BRISTOL MYERS SQUIBB BRASIL SA received?

BRISTOL MYERS SQUIBB BRASIL SA has been cited for 1 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 BRASIL SA come from?

All FDA import refusal data for BRISTOL MYERS SQUIBB BRASIL SA 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.