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LABORATORIOS TOCOGINO S.A. DE C.

⚠️ Moderate Risk

FEI: 3012970251 • CHIHUAHUA • MEXICO

FEI

FEI Number

3012970251

📍

Location

CHIHUAHUA

🇲🇽

Country

MEXICO
🏢

Address

NO 185 COL ROMA, , CHIHUAHUA, , Mexico

Moderate Risk

FDA Import Risk Assessment

48.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
9/2/2022
Latest Refusal
1/4/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
18.0×20%
Frequency
7.1×10%
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

754×

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
9/2/2022
56GDY99ANTIFUNGAL N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/28/2019
64NCK07IRON DEXTRAN (INJ) (HEMATINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/23/2017
60QCJ07LIDOCAINE
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/4/2017
64LDB27FLUOCINOLONE ACETONIDE (GLUCOCORTICOID)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is LABORATORIOS TOCOGINO S.A. DE C.'s FDA import refusal history?

LABORATORIOS TOCOGINO S.A. DE C. (FEI: 3012970251) has 4 FDA import refusal record(s) in our database, spanning from 1/4/2017 to 9/2/2022.

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 TOCOGINO S.A. DE C.'s FEI number is 3012970251.

What types of violations has LABORATORIOS TOCOGINO S.A. DE C. received?

LABORATORIOS TOCOGINO S.A. DE C. has been cited for 1 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 TOCOGINO S.A. DE C. come from?

All FDA import refusal data for LABORATORIOS TOCOGINO S.A. DE C. 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.