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Evodia Laboratorios

⚠️ Moderate Risk

FEI: 3010549237 • D.n., Distrito Nacional • DOMINICAN REPUBLIC

FEI

FEI Number

3010549237

📍

Location

D.n., Distrito Nacional

🇩🇴
🏢

Address

Av Independencia 260, , Santo Domingo, D.n., Distrito Nacional, Dominican Republic

Moderate Risk

FDA Import Risk Assessment

33.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
1/7/2014
Latest Refusal
1/7/2014
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

4736×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
1/7/2014
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
San Juan District Office (SJN-DO)
1/7/2014
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
San Juan District Office (SJN-DO)
1/7/2014
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
San Juan District Office (SJN-DO)
1/7/2014
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
San Juan District Office (SJN-DO)
1/7/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
San Juan District Office (SJN-DO)
1/7/2014
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
San Juan District Office (SJN-DO)
1/7/2014
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Evodia Laboratorios's FDA import refusal history?

Evodia Laboratorios (FEI: 3010549237) has 7 FDA import refusal record(s) in our database, spanning from 1/7/2014 to 1/7/2014.

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. Evodia Laboratorios's FEI number is 3010549237.

What types of violations has Evodia Laboratorios received?

Evodia Laboratorios has been cited for 2 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 Evodia Laboratorios come from?

All FDA import refusal data for Evodia Laboratorios 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.