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LABORATORIOS BEST S.A. DE CV OL

⚠️ High Risk

FEI: 3021926636 • Jalisco • MEXICO

FEI

FEI Number

3021926636

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

2804 Col Alamo Industri, , Jalisco, , Mexico

High Risk

FDA Import Risk Assessment

55.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
2
Unique Violations
10/29/2025
Latest Refusal
10/12/2022
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
95.4×20%
Frequency
6.6×10%
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

752×

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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
10/29/2025
64LCB13DEXAMETHASONE ACETATE (GLUCOCORTICOID)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2022
60LCJ99ANALGESIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS BEST S.A. DE CV OL's FDA import refusal history?

LABORATORIOS BEST S.A. DE CV OL (FEI: 3021926636) has 2 FDA import refusal record(s) in our database, spanning from 10/12/2022 to 10/29/2025.

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 BEST S.A. DE CV OL's FEI number is 3021926636.

What types of violations has LABORATORIOS BEST S.A. DE CV OL received?

LABORATORIOS BEST S.A. DE CV OL 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 S.A. DE CV OL come from?

All FDA import refusal data for LABORATORIOS BEST S.A. DE CV OL 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.