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Laboratorio Santa Fe, S.A.

⚠️ Moderate Risk

FEI: 3003666341 • Valle Del Sol • GUATEMALA

FEI

FEI Number

3003666341

📍

Location

Valle Del Sol

🇬🇹

Country

GUATEMALA
🏢

Address

Lote 18 Manzana "E", , Valle Del Sol, , Guatemala

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/9/2009
Latest Refusal
6/9/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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).

Refusal History

DateProductViolationsDivision
6/9/2009
54GCL99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C.
11UNSAFE COL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Laboratorio Santa Fe, S.A.'s FDA import refusal history?

Laboratorio Santa Fe, S.A. (FEI: 3003666341) has 1 FDA import refusal record(s) in our database, spanning from 6/9/2009 to 6/9/2009.

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. Laboratorio Santa Fe, S.A.'s FEI number is 3003666341.

What types of violations has Laboratorio Santa Fe, S.A. received?

Laboratorio Santa Fe, S.A. 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 Laboratorio Santa Fe, S.A. come from?

All FDA import refusal data for Laboratorio Santa Fe, S.A. 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.