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LABORATORIOS GROSSMAN SA DE V

⚠️ High Risk

FEI: 3021013778 • Coyoacan • MEXICO

FEI

FEI Number

3021013778

📍

Location

Coyoacan

🇲🇽

Country

MEXICO
🏢

Address

Calz De Tlalpan No 0404, , Coyoacan, , Mexico

High Risk

FDA Import Risk Assessment

51.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
4/26/2023
Latest Refusal
11/10/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
30.7×20%
Frequency
30.0×10%
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

753×

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
4/26/2023
61SCJ99ANTI-ECZEMATIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/30/2022
65RDL99REPLENISHER N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/10/2022
62GCJ99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS GROSSMAN SA DE V's FDA import refusal history?

LABORATORIOS GROSSMAN SA DE V (FEI: 3021013778) has 3 FDA import refusal record(s) in our database, spanning from 11/10/2022 to 4/26/2023.

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 GROSSMAN SA DE V's FEI number is 3021013778.

What types of violations has LABORATORIOS GROSSMAN SA DE V received?

LABORATORIOS GROSSMAN SA DE V 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 GROSSMAN SA DE V come from?

All FDA import refusal data for LABORATORIOS GROSSMAN SA DE V 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.