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LABORATORIOS GRIN SA DE CV

⚠️ High Risk

FEI: 3013230057 • Benito Juarez • MEXICO

FEI

FEI Number

3013230057

📍

Location

Benito Juarez

🇲🇽

Country

MEXICO
🏢

Address

Rodriguez Saro NO 630 C, , Benito Juarez, , Mexico

High Risk

FDA Import Risk Assessment

55.6
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
9/24/2025
Latest Refusal
9/23/2019
Earliest Refusal

Score Breakdown

Violation Severity
78.0×40%
Refusal Volume
25.9×30%
Recency
79.7×20%
Frequency
6.7×10%
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).

4721×

NO ENGLISH

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

Refusal History

DateProductViolationsDivision
9/24/2025
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/14/2025
62VDC29IMIQUIMOD (ANTI-VIRAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/22/2022
56DDK80TOBRAMYCIN SULFATE (AMINOGLYCOSIDES)
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/23/2019
56DDL80TOBRAMYCIN SULFATE (AMINOGLYCOSIDES)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS GRIN SA DE CV's FDA import refusal history?

LABORATORIOS GRIN SA DE CV (FEI: 3013230057) has 4 FDA import refusal record(s) in our database, spanning from 9/23/2019 to 9/24/2025.

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 GRIN SA DE CV's FEI number is 3013230057.

What types of violations has LABORATORIOS GRIN SA DE CV received?

LABORATORIOS GRIN SA DE CV 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 GRIN SA DE CV come from?

All FDA import refusal data for LABORATORIOS GRIN SA DE CV 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.