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BIOLAB SANUS FARMACEUTICA LTDA

⚠️ High Risk

FEI: 3019973559 • S O Paulo • BRAZIL

FEI

FEI Number

3019973559

📍

Location

S O Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Solange Aparecid, 49, , S O Paulo, , Brazil

High Risk

FDA Import Risk Assessment

59.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
11/12/2025
Latest Refusal
11/12/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
96.8×20%
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
11/12/2025
54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BIOLAB SANUS FARMACEUTICA LTDA's FDA import refusal history?

BIOLAB SANUS FARMACEUTICA LTDA (FEI: 3019973559) has 1 FDA import refusal record(s) in our database, spanning from 11/12/2025 to 11/12/2025.

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. BIOLAB SANUS FARMACEUTICA LTDA's FEI number is 3019973559.

What types of violations has BIOLAB SANUS FARMACEUTICA LTDA received?

BIOLAB SANUS FARMACEUTICA LTDA 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 BIOLAB SANUS FARMACEUTICA LTDA come from?

All FDA import refusal data for BIOLAB SANUS FARMACEUTICA LTDA 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.