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Grupo Rostenberg, S.A. de C.V.

⚠️ High Risk

FEI: 3016814017 • Deleg. Iztapalapa • MEXICO

FEI

FEI Number

3016814017

📍

Location

Deleg. Iztapalapa

🇲🇽

Country

MEXICO
🏢

Address

Calle 11 de Agosto de 1859 No. 115 Col. Leyes de Reforma, , Deleg. Iztapalapa, , Mexico

High Risk

FDA Import Risk Assessment

56.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/15/2024
Latest Refusal
12/15/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
78.4×20%
Frequency
10.0×10%
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

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
12/15/2024
66VCE99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Grupo Rostenberg, S.A. de C.V.'s FDA import refusal history?

Grupo Rostenberg, S.A. de C.V. (FEI: 3016814017) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2024 to 12/15/2024.

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. Grupo Rostenberg, S.A. de C.V.'s FEI number is 3016814017.

What types of violations has Grupo Rostenberg, S.A. de C.V. received?

Grupo Rostenberg, S.A. de C.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 Grupo Rostenberg, S.A. de C.V. come from?

All FDA import refusal data for Grupo Rostenberg, S.A. de C.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.