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VANILSON FERREIRA DOS SANTOS

⚠️ Moderate Risk

FEI: 3023505440 • Macae, Rio de Janeiro • BRAZIL

FEI

FEI Number

3023505440

📍

Location

Macae, Rio de Janeiro

🇧🇷

Country

BRAZIL
🏢

Address

Rua Jose Linhares, Q6, Bl 2, Macae, Rio de Janeiro, Brazil

Moderate Risk

FDA Import Risk Assessment

49.3
LowModerateHighCritical

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

Statistics

9
Total Refusals
3
Unique Violations
10/6/2022
Latest Refusal
10/6/2022
Earliest Refusal

Score Breakdown

Violation Severity
62.7×40%
Refusal Volume
37.0×30%
Recency
20.4×20%
Frequency
90.0×10%
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

1189×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

759×

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).

4724×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
10/6/2022
66FCA05COLCHICINE (SUPPRESSANT)
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
61TCK31DOMPERIDONE
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
60SBR07PRECIPITATED CALCIUM CARBONATE (ANTACID)
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
60LDA01ACETAMINOPHEN (ANALGESIC)
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
61XDK16DEXCHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
60ZRR02ALBENDAZOLE (ANTIPARASITIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
60ZQA02ALBENDAZOLE (ANTIPARASITIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
60CRL43MEPHENTERMINE SULFATE (ADRENERGIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/6/2022
64BCQ48INDAPAMIDE (DIURETIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is VANILSON FERREIRA DOS SANTOS's FDA import refusal history?

VANILSON FERREIRA DOS SANTOS (FEI: 3023505440) has 9 FDA import refusal record(s) in our database, spanning from 10/6/2022 to 10/6/2022.

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. VANILSON FERREIRA DOS SANTOS's FEI number is 3023505440.

What types of violations has VANILSON FERREIRA DOS SANTOS received?

VANILSON FERREIRA DOS SANTOS has been cited for 3 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 VANILSON FERREIRA DOS SANTOS come from?

All FDA import refusal data for VANILSON FERREIRA DOS SANTOS 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.