ImportRefusal LogoImportRefusal

LABORATORIOS BEST

⚠️ Moderate Risk

FEI: 3013635735 • Nicolas Tolentino • MEXICO

FEI

FEI Number

3013635735

📍

Location

Nicolas Tolentino

🇲🇽

Country

MEXICO
🏢

Address

Bilbao No 281, Col An, Nicolas Tolentino, , Mexico

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/22/2022
Latest Refusal
9/22/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
19.9×20%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
9/22/2022
61WCA46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS BEST's FDA import refusal history?

LABORATORIOS BEST (FEI: 3013635735) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2022 to 9/22/2022.

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 BEST's FEI number is 3013635735.

What types of violations has LABORATORIOS BEST received?

LABORATORIOS BEST 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 BEST come from?

All FDA import refusal data for LABORATORIOS BEST 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.