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GRUPO RAZEL SA DE CV / Laboratorios RAZEL

⚠️ Moderate Risk

FEI: 3009080145 • San Salvador, San Salvador • EL SALVADOR

FEI

FEI Number

3009080145

📍

Location

San Salvador, San Salvador

🇸🇻
🏢

Address

Avenida C # 122, Colonia El Roble, , San Salvador, San Salvador, El Salvador

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/14/2011
Latest Refusal
12/14/2011
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

DateProductViolationsDivision
12/14/2011
54ACY90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is GRUPO RAZEL SA DE CV / Laboratorios RAZEL's FDA import refusal history?

GRUPO RAZEL SA DE CV / Laboratorios RAZEL (FEI: 3009080145) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2011 to 12/14/2011.

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. GRUPO RAZEL SA DE CV / Laboratorios RAZEL's FEI number is 3009080145.

What types of violations has GRUPO RAZEL SA DE CV / Laboratorios RAZEL received?

GRUPO RAZEL SA DE CV / Laboratorios RAZEL 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 GRUPO RAZEL SA DE CV / Laboratorios RAZEL come from?

All FDA import refusal data for GRUPO RAZEL SA DE CV / Laboratorios RAZEL 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.