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LABORATORIOS ENERXIS S.A.S

⚠️ Moderate Risk

FEI: 3015165677 • Bogota, Cundinamarca • COLOMBIA

FEI

FEI Number

3015165677

📍

Location

Bogota, Cundinamarca

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 93 60b 82, , Bogota, Cundinamarca, Colombia

Moderate Risk

FDA Import Risk Assessment

42.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/29/2025
Latest Refusal
8/29/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
92.6×20%
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

4731×

LABELING

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

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
8/29/2025
54YCU99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
473LABELING
488HEALTH C
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS ENERXIS S.A.S's FDA import refusal history?

LABORATORIOS ENERXIS S.A.S (FEI: 3015165677) has 1 FDA import refusal record(s) in our database, spanning from 8/29/2025 to 8/29/2025.

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. LABORATORIOS ENERXIS S.A.S's FEI number is 3015165677.

What types of violations has LABORATORIOS ENERXIS S.A.S received?

LABORATORIOS ENERXIS S.A.S 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 LABORATORIOS ENERXIS S.A.S come from?

All FDA import refusal data for LABORATORIOS ENERXIS S.A.S 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.