ImportRefusal LogoImportRefusal

SOLUCIONES EN BIOSEGURIDAD AMBIE

⚠️ Moderate Risk

FEI: 3020103474 • Zapopam Jalisco, COL. • MEXICO

FEI

FEI Number

3020103474

📍

Location

Zapopam Jalisco, COL.

🇲🇽

Country

MEXICO
🏢

Address

Bahia Escondida 60, , Zapopam Jalisco, COL., Mexico

Moderate Risk

FDA Import Risk Assessment

34.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/6/2021
Latest Refusal
12/6/2021
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
18.0×20%
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

38831×

708NODFL

The article lacks an OTC "Drug Facts" label as required by 21 CFR 201.66.

751×

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).

Refusal History

DateProductViolationsDivision
12/6/2021
64ABK99DISINFECTANT N.E.C.
3883708NODFL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SOLUCIONES EN BIOSEGURIDAD AMBIE's FDA import refusal history?

SOLUCIONES EN BIOSEGURIDAD AMBIE (FEI: 3020103474) has 1 FDA import refusal record(s) in our database, spanning from 12/6/2021 to 12/6/2021.

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. SOLUCIONES EN BIOSEGURIDAD AMBIE's FEI number is 3020103474.

What types of violations has SOLUCIONES EN BIOSEGURIDAD AMBIE received?

SOLUCIONES EN BIOSEGURIDAD AMBIE 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 SOLUCIONES EN BIOSEGURIDAD AMBIE come from?

All FDA import refusal data for SOLUCIONES EN BIOSEGURIDAD AMBIE 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.