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Laboratorios Florigan

⚠️ Moderate Risk

FEI: 3023824666 • Jalisco • MEXICO

FEI

FEI Number

3023824666

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Av. Atemajac 1407, , Jalisco, , Mexico

Moderate Risk

FDA Import Risk Assessment

34.6
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
10/5/2022
Latest Refusal
10/5/2022
Earliest Refusal

Score Breakdown

Violation Severity
47.1×40%
Refusal Volume
25.9×30%
Recency
19.8×20%
Frequency
40.0×10%
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

4713×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4753×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

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
10/5/2022
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)
10/5/2022
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)
10/5/2022
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)
10/5/2022
54YYO99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Laboratorios Florigan's FDA import refusal history?

Laboratorios Florigan (FEI: 3023824666) has 4 FDA import refusal record(s) in our database, spanning from 10/5/2022 to 10/5/2022.

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 Florigan's FEI number is 3023824666.

What types of violations has Laboratorios Florigan received?

Laboratorios Florigan has been cited for 3 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 Florigan come from?

All FDA import refusal data for Laboratorios Florigan 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.