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BOTANE PHARM

⚠️ High Risk

FEI: 3040898948 • Rio De Janeiro, Rio de Janeiro • BRAZIL

FEI

FEI Number

3040898948

📍

Location

Rio De Janeiro, Rio de Janeiro

🇧🇷

Country

BRAZIL
🏢

Address

Av Das Americas, 2480, , Rio De Janeiro, Rio de Janeiro, Brazil

High Risk

FDA Import Risk Assessment

67.2
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/26/2025
Latest Refusal
11/26/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
97.3×20%
Frequency
40.0×10%
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

754×

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
11/26/2025
61PDE73EMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/26/2025
64MCE01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/26/2025
54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/26/2025
54YGE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BOTANE PHARM's FDA import refusal history?

BOTANE PHARM (FEI: 3040898948) has 4 FDA import refusal record(s) in our database, spanning from 11/26/2025 to 11/26/2025.

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. BOTANE PHARM's FEI number is 3040898948.

What types of violations has BOTANE PHARM received?

BOTANE PHARM 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 BOTANE PHARM come from?

All FDA import refusal data for BOTANE PHARM 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.