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Abbott Laboratories Do Brasil Lt

⚠️ Moderate Risk

FEI: 3004358637 • Sao Paulo • BRAZIL

FEI

FEI Number

3004358637

📍

Location

Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Caixa Postal No 21, , 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
1/4/2005
Latest Refusal
1/4/2005
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
1/4/2005
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Abbott Laboratories Do Brasil Lt's FDA import refusal history?

Abbott Laboratories Do Brasil Lt (FEI: 3004358637) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2005 to 1/4/2005.

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. Abbott Laboratories Do Brasil Lt's FEI number is 3004358637.

What types of violations has Abbott Laboratories Do Brasil Lt received?

Abbott Laboratories Do Brasil Lt 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 Abbott Laboratories Do Brasil Lt come from?

All FDA import refusal data for Abbott Laboratories Do Brasil Lt 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.